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spread use of the wheel, some 6,000 years ago. ... As I read the article that accompanied the list, I noted the industries .... When we couple modular design with continuous man- .... Shah has spent 19 years in biopharma manufacturing with the likes ..... manufacturing sites, companies were able to not only reduce their.
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Empowered Manufacturing:

A Firsthand Look At

GSK p. 16

M I C H A E L S Z Y M A N S KI Site Director, GSK Marietta, PA

INSIDE THIS EBOOK:

Manufacturing 4

Merck 10

Leadership 30

Are You Ready For The Future Of Biopharma Manufacturing?

Sanat Chattopadhyay: Shaping Merck’s Manufacturing Future

Jim Robinson Offers Leadership Advice In “Plant Management 101”

A LIFE SCIENCE LEADER EBOOK

Contents 2018 BIOPHARMA MANUFACTURING EBOOK

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FROM THE EDITOR

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What Would Innovation Be Without Manufacturing?

Not Your Typical Biopharma Manufacturing Career Path

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Are You Ready For The Future Of Biopharma Manufacturing?

You Can Do Everything Right, But

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BIG PHARMA MANUFACTURING

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Sanat Chattopadhyay — Shaping Merck’s Manufacturing Future

Our editorial board answers manufacturing-focused questions

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LESSONS LEARNED

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Successful Transformations Require A Post-Period Of Reflection

Consent Decrees And Other Formative Site-Leadership Experiences

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GSK Manufacturing — Enabling Cultural Development At The Site Level

Plant Management 101

OPERATIONS

INDUSTRY OUTLOOK

OUTSOURCING

2018 BIOPHARMA MANUFACTURING EBOOK

Still Get Burned By Outsourcing

ASK THE BOARD

OPERATIONS

INSIGHTS FROM A SITE TOUR

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LEADERSHIP LESSONS

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EDITOR’S NOTE

LIFE SCIENCE LEADER 5340 Fryling Rd., Suite 300 Erie, PA 16510-4672 Telephone: 814 897 7700 Fax: 814 899 5587 WWW.LIFESCIENCELEADER.COM CEO Jon Howland / Ext. 203 [email protected] EDITORIAL DIRECTOR Dan Schell / Ext. 284 [email protected] CHIEF EDITOR Rob Wright / Ext. 140 [email protected] EXECUTIVE EDITOR Wayne Koberstein [email protected] EDITORS Louis Garguilo [email protected] Bob Marshall [email protected] Ed Miseta [email protected] Anna Rose Welch [email protected] VP OF AUDIENCE DEVELOPMENT Michael Bennett [email protected] STRATEGIC PARTNERSHIPS/BUS. DEV. Tim Bretz / 724-940-7555 / Ext. 123 [email protected] Cory Coleman / 724-940-7555 / Ext. 125 [email protected] Scott Moren / Ext. 118 [email protected] Denise Mosley / 724-940-7555 / Ext. 126 [email protected] Shannon Primavere / Ext. 279 [email protected] Perry Rearick / Ext. 263 [email protected] Ray Sherman / Ext. 335 [email protected] Tracy Tasker / Ext. 297 [email protected] Derek Van Slyke / Ext. 217 [email protected] Casey Weed / Ext. 219 [email protected] DATA ANALYTICS Rick Miller [email protected] Kevin Morey [email protected] PRODUCTION DIRECTOR Lynn Netkowicz / Ext. 205 [email protected]

What Would Innovation Be Without Manufacturing? R O B W R I G H T Chief Editor

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ver ponder what might be the 50 greatest breakthroughs since the invention of the wheel? Would your list include vaccination, the pill, or penicillin? Outside of healthcare, would you include the internet, refrigeration, or the airplane? How about dated inventions such as alphabetization, the telegraph, or the Gregorian calendar? In 2013, The Atlantic assembled a panel of 12 scientist, engineers, technology historians, and others to assess the innovations that have done the most to shape modern life. The main rule imposed for the exercise was that the innovations should have come after widespread use of the wheel, some 6,000 years ago. The Atlantic published its list of 50 in November 2013, and you may (or may not) be surprised to learn it included all of the innovations noted in the previous paragraph. As I read the article that accompanied the list, I noted the industries associated with each of the innovations. For example, the airplane (ranking 15 on the list) belonged to transportation. Healthcare innovations included penicillin (3), optical lenses (5), vaccination (8), sanitation systems (12), The Pill (20), and anesthesia (46). But some innovations have industry overlap. For example, the internet (9) could certainly be classified within the computer industry, but given its evolution wouldn’t it also have ties to entertainment, education, financial services, mass media, and publishing, just to name a few. But then I looked at the list and asked, “Which of these innovations are dependent upon manufacturing?” After all, nearly all required some level of manufacturing to have had their impact. The first printing press (1) may have been handcrafted, but subsequent iterations were manufactured. To develop, harvest, or distribute electricity (2) requires enormous amounts of industrial support in the form of manufactured turbines, solar panels, wire coils, and so much more. In fact, of the 50 innovations listed by The Atlantic, you might be able to argue that only one, alphabetization (25), didn’t require manufacturing for it to be beneficial, but the argument would be tenuous at best. For alphabetization led to the printed word, the advent of the printing press, and the massive spread of knowledge. As you weigh the importance of manufacturing and its impact on nearly everything it touches, you also might want to consider what is necessary to manufacture successfully, beyond electricity, machines, and the supply chain. Manufacturing requires more than robust processes, talented people, and superior support networks. For without the indispensable component of leadership and the ability of leaders to effectively communicate what needs to be done, the possibility of getting every member of a manufacturing facility or organization all rowing in the same direction is greatly diminished. To that end, Life Science Leader created this special biopharmaceutical industry manufacturing e-book and engaged manufacturing executives from the site level all the way up to the c-suite for their insight. We hope you enjoy what they have to say and remember the important role you play. For without the backing of manufacturing, innovations would never successfully be delivered to patients, but remain ideas on a whiteboard — undelivered and unfulfilled. L facebook.com/LifeScienceLeader @RfwrightLSL linkedin.com/in/robertfwright

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Leaders

2018 INDUSTRY OUTLOOK

ARE YOU READY FOR THE FUTURE OF BIOPHARMA MANUFACTURING?

By R. Wright

Are You Ready For The Future Of Biopharma Manufacturing? R O B W R I G H T Chief Editor

@RfwrightLSL

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n last’s year’s manufacturing outlook we delved into biopharma’s manufacturing capacity crunch. While lack of manufacturing capacity remains a challenge for the industry, the future of biopharma manufacturing has never looked so bright, and there is a variety of reasons why. For starters, when it comes to innovation in manufacturing, biopharma companies continue to push the envelope. Want proof? Take a quick review of the ISPE Facility of the Year Awards (FOYA), an annual program recognizing state-of-the-art projects by biopharma manufacturers. There you’ll see some old standbys (e.g., Abbott, Bristol-Myers Squibb, and Lilly) being recognized for operational excellence (OPEX), facility integration, and process innovation, but you’ll also encounter some lesser-known names. For example, Kalbio Global Medika’s young team (average age of 24) received an honorable mention for its 40,000-square-foot biotechnology manufacturing build in Jakarta, Indonesia. Nephron Pharmaceuticals Corp., another honorable mention, is a woman-owned business that also happens to be the world’s largest blow-fill-seal manufacturer. Another reason for optimism is the volume of incredible technological innovations beginning to make their way into biopharma manufacturing operations. Beyond those technologies, though, is the talent that will ensure proper implementation. With that in mind, for this year’s manufacturing outlook we assembled the biggest

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and most diverse group of biopharma manufacturing thought leaders ever. You’ll hear from Big Pharma, virtual biopharma, and U.S. regulatory leadership, as well as international perspectives, for what to expect in biopharma manufacturing for 2018 — and beyond. So let’s begin.

WHAT INNOVATIVE SOLUTIONS TO THE CURRENT BIOPHARMA INDUSTRY MANUFACTURING CAPACITY CRUNCH NEED TO BE IMPLEMENTED TO MEDIATE THE PROBLEM?

Paul McKenzie, Ph.D. EVP Pharmaceutical Operations & Technology Biogen As the pipelines of innovators continue to diversify across modalities, every company will face the challenge of building needed capabilities for all modalities, while maintaining existing capacities and capabilities consumed by the current portfolio. In addition to this diversification, the productivity of more mature modality platforms is increasing significantly, driving current facilities to be underutilized or in need of redesign. This inflection point will create the need for different partnership models amongst innovator companies, as well as between innovator companies, CMOs, and laboratory organizations. Since owning everything will be a signif-

icant financial burden, the onus will be on each company to clearly delineate what it can manage and access through these partnerships.

WHAT DISRUPTIVE TECHNOLOGIES WILL TRANSFORM BIOPHARMA MANUFACTURING IN THE NEXT THREE TO FIVE YEARS?

Wolfram Carius, Ph.D. Head of Pharmaceuticals Product Supply Bayer Gene and cell therapy seem to be at the edge of having a transformative impact on different therapeutic areas such as oncology, immunology, or hematology. This will intensify beyond the five-year horizon as advanced technologies like CRISPR-Cas9 or viral vectors will accelerate innovation tailored to patients. This too, will significantly transform the value chain and operating model in the market within the biopharma industry. Drug-device combinations, be they for diagnostics, IT support (e.g. monitoring compliance), or drug application, also will increase, making an end-to-end setup of our organizations ever more important. At the same time, both improvements and step changes through advanced analytics and artificial intelligence (AI) also will reach the pharmaceutical sector, not just in clini-

cal development but probably also initially in supply chain and quality and then in technical development and manufacturing. Big Data managed along the entire supply chain will provide real-time transparency, and many supply chain process steps could be performed by self-learning computer systems. Robotics and evolution toward real-time controls through advanced analytics will further improve cGMP compliance and product quality by speeding up process robustness and quality control, thus also accelerating technical development and manufacturing, which will be on a steady, critical path for new product launches.

WHAT BIOPHARMA MANUFACTURING TRENDS DO YOU FIND MOST EXCITING?

Roger Connor President Global Manufacturing & Supply GSK When we couple modular design with continuous manufacturing, then we can truly create a flexible pharmaceutical manufacturing space that is genuinely transformative. The footprint and equipment scale of these modular-design continuous plants will be completely different from what we know today and will enable significant reduction in operating costs while virtually LIFESCIENCELEADER.COM

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2018 INDUSTRY OUTLOOK

ARE YOU READY FOR THE FUTURE OF BIOPHARMA MANUFACTURING?

By R. Wright

JANET WOODCOCK ADDRESSES BIOPHARMA MANUFACTURING’S FUTURE

As the Director for the CDER and an FDA employee since 1986, Janet Woodcock, M.D., holds a special place in the world of biopharma manufacturing. Under her leadership, we have witnessed the introduction of risk management as a new approach to drug safety, the “Critical Path” Initiative to move medical discoveries from the laboratory to consumers more efficiently, and the “Pharmaceutical Quality for the 21st Century Initiative,” the FDA’s highly successful effort to modernize drug manufacturing and its regulation. Here is Dr. Woodcock’s biopharma manufacturing outlook for 2018 — and beyond. WHAT DISRUPTIVE TECHNOLOGIES WILL TRANSFORM BIOPHARMA INDUSTRY MANUFACTURING IN THE NEXT THREE TO FIVE YEARS? We will continue to see the adoption of continuous manufacturing technologies. These technologies may soon begin to integrate drug substance and drug product manufacturing in the small molecule space and upstream and downstream processing in the biological product space. This should be a positive trend as it can potentially enable higher product quality, lower manufacturing costs, smaller facility footprints, and improved agility. Coupled with this, we also may see advancements in process analytical technology (PAT) and model-based control strategies enabling real-time monitoring of product quality at unprecedented frequencies and real-time product release decisions without end product testing. Also on the horizon are new dosage forms enabled by additive and other manufacturing technologies that can accommodate specialized patient needs. For example, this might include easy-to-swallow drugs or drugs with specific release rates. These technologies may even be mobile or on-demand. These smaller manufacturing platforms may enable on-site drug manufacturing at pharmacies, hospitals, or sites of public health emergencies. The rise of digital medicine also could allow us to more closely link drug quality to individual patient impact than ever before. WHAT IS YOUR VISION FOR HOW THE GLOBAL BIOPHARMA MANUFACTURING INDUSTRY COULD LOOK IN 2028 AND BEYOND? Currently, the pharmaceutical manufacturing industry is still entering the stage of automation, while other industries are entering the stage of cyber-physical systems or Industry 4.0. Some in the FDA recently described a future vision of pharmaceutical quality and a potential path to get there. That future is Six Sigma pharmaceutical quality (i.e., no more than 3.4 defects per million opportunities). A path to get there includes economic drivers, performance-based regulation, Quality by

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Design (QbD), advanced manufacturing technologies, and continuous improvement and operational excellence (OPEX). To realize this future there need to be economic factors that recognize and incentivize quality. The regulatory approach must shift from predominantly management-based regulation to performance-based in order to give industry the necessary flexibility to improve quality. The adoption of emerging manufacturing technologies, including continuous manufacturing and advanced PAT, can enable higher quality. The knowledge gained from a QbD approach forms the basis for establishing a control strategy for these technologies. Finally, continuous improvement, OPEX, and a culture of quality must be part of the overall effort to drive quality in an organization. It is not unreasonable to think that the pharmaceutical manufacturing industry could follow this path to Six Sigma quality over the next decade. WHAT ARE YOU DOING THAT WILL HAVE A BIG IMPACT ON YOUR MANUFACTURING ORGANIZATION IN 2018 AND BEYOND? The CDER has an Emerging Technology Program to promote early engagement with firms to discuss potential challenges in implementing innovative approaches to pharmaceutical product design and manufacturing. We recently issued a final guidance for industry, “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization,” with recommendations for firms that are interested in discussing these emerging technologies with the FDA. We recognize that adopting innovative approaches can present technical and regulatory challenges, including concerns about delays in the regulatory assessment process. With early engagement, the FDA can move more quickly to assess and act on applications involving new technologies. Along with this initiative, we have made an effort to provide staff with the knowledge necessary to handle such applications. Much of this knowledge stems from our research in both PAT and manufacturing science, which provides learning opportunities for our staff involved in application assessment. We’ve also taken steps to more fully integrate the human drug-assessment programs with facility evaluations and inspections. This enables better alignment between our field professionals and the staff who evaluate the products manufactured in the inspected facilities. The Emerging Technology Program could have a big impact on manufacturers in 2018 and beyond due to the potential for early face-to-face meetings even before identifying a lead drug molecule. These interactions then continue to provide regulatory feedback and facilitate the preparation of a regulatory submission.

WHAT ARE THE TOP EMERGING INNOVATIONS THAT WILL IMPACT BIOPHARMA MANUFACTURING WITHIN THE NEXT FIVE YEARS?

“WHEN WE COUPLE MODULAR DESIGN WITH CONTINUOUS MANUFACTURING, THEN WE CAN TRULY CREATE A FLEXIBLE PHARMACEUTICAL MANUFACTURING SPACE THAT IS GENUINELY TRANSFORMATIVE." Roger Connor President Global Manufacturing & Supply, GSK

eliminating plant changeover time loss and freeing up capacity. Our networks will become far more flexible, and construction costs will decrease. Within the next 10 years, we could even see portable manufacturing facilities. The opportunities for continuous processing in API manufacturing are particularly interesting and should provide far more robust and reproducible manufacturing platforms with significant scope for automation. Coupled with online analysis, which can shorten batch release times and improve data integrity, continuous processing will significantly reduce processing time.

WHAT MANUFACTURING TRENDS FROM OTHER INDUSTRIES WILL BEGIN TO SPILL OVER INTO BIOPHARMA IN 2018 AND BEYOND?

Robert Stewart EVP, COO Allergan Pharma is still behind many other industries regarding investments in technology involving how businesses are run, compared with how products are made. We see the potential for continued investment and improvement here, learning from the fast-moving consumer goods and electronics industries which have demonstrated a proclivity for using much of today’s innovation (e.g., cloud computing and the Internet of Things ) to increase visibility to data and other trends to facilitate fast and more agile decision making across supply chains.

Philippe Luscan EVP Global Industrial Affairs Sanofi Certainly the way data can be exploited through cloud computing and the Industrial Internet of Things, for example, to enhance more effective and quicker decision making is a definite benefit. However, there is a perception that the biopharma industry has been behind the times in adopting some new approaches, but we should bear in mind that these emerging innovations come with unique risks that need to be managed carefully. For example, despite the obvious benefits of cloud computing, particularly in clinical research, it is imperative we keep any patient-sensitive data secure. How much risk a company is willing to take in this respect is likely to vary from one organization to another. While we should always proceed in new ways of working with necessary caution, it is certainly an exciting time to be involved in biopharma manufacturing, as ultimately all of these technologies will feed on one another as they mature.

WHAT IS YOUR VISION FOR HOW THE GLOBAL BIOPHARMA MANUFACTURING INDUSTRY COULD LOOK IN 2028 AND BEYOND?

Chun Zhang, Ph.D. Head of Process Development & Manufacturing Evelo Biosciences The industry will consist of several segments tailored to product platforms such as proteins, cell therapies, and gene therapies. They also will consist of different scales to meet the diverse product needs, ranging from blockbuster to individualized medicine. Large manufacturing plants are more cost-effective for commodity-type products, while smaller modular facilities will be tailored for niche products. Continuous manufacturing will be widely adopted and greatly enhance productivity and product quality, and true integration of information and data will enable rapid analysis and fast decision making. There will be much closer collaboration between manufacturers and suppliers in precompetitive consortia to drive standardization and automation, and as a result, supply chains will be more integrated and efficient in reducing inventory hold. LIFESCIENCELEADER.COM

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By R. Wright

INSIGHTS FROM A BIOPHARMA MANUFACTURING TRAILBLAZER

ARE YOU READY FOR THE FUTURE OF BIOPHARMA MANUFACTURING?

Across races, females are earning more undergraduate degrees than their male counterparts, including disciplines of science and engineering. Why then are 38 percent of female engineers opting to leave their field? According to a national study, 30 percent of respondents cited an organizational climate characterized by nonsupportive supervisors or co-workers and general incivility, while nearly half left due to working conditions. So despite there being more women in biopharma manufacturing leadership roles, there aren’t as many as there should be. This issue isn’t related to female self-confidence or leaving the workforce for motherhood; it’s a field that lacks a strong network of female leaders, necessitating aspiring women to have to blaze their own trail. Chhaya Shah, one of two women trailblazers to participate in this year’s manufacturing outlook, has had to overcome her share of adversity. For example, when she moved to the United States from India at the age of eight, she did not speak any English. Yet Shah went on to graduate from high school with honors. In her graduating class of over 3,000 students at Wilkes University, there were only three women (including her) in the college’s engineering program. Shah has spent 19 years in biopharma manufacturing with the likes of Becton Dickenson, Abbott, Wyeth, and Shire, before taking on her current role as SVP of manufacturing and technical operations at Synergy Pharmaceuticals (NASDAQ: SGYP). Her perspectives are as diverse as her experiences — and they do not include a mention of the need for more women in biopharma leadership. IS THERE A CURRENT BIOPHARMA MANUFACTURING TREND THAT HAS BEGUN TO DIE? The traditional hierarchical organizational structure is not likely to last much longer. More companies are moving toward a teambased organizational structure. Top-down hierarchical organizations were originally designed for accountability. However, for successful organizations to compete and win in today’s global market, they must be designed for speed, agility, and adaptability. As organizations make the transition to a team-based approach, they find smaller teams (i.e., five to seven people) to be a more natural way for employees to work. Whatever a hierarchical organizational chart says, real, day-to-day work is done in networks. Therefore, the organization of the future is a network of teams that are accountable for results and given the freedom to drive the required decision making to achieve them. Top-performing companies are built on systems that encourage teams and individuals to meet each other, share information transparently, and move from team-to-team depending on issues to be addressed. Different networks may have different specialties, such as innovation or getting a product to market quickly, but the principle is the same. Launching a product is a great example of where you need a team that is agile, networked, 8

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effective, efficient, and sharing a common goal. New organizational models also will require new approaches to leadership, and leaders of a teambased approach will need skills in the area of talent development, negotiation, resilience, and system thinking. WHAT REGION OTHER THAN THE U.S. WILL HAVE THE BIGGEST IMPACT ON BIOPHARMA MANUFACTURING IN THE NEXT THREE TO FIVE YEARS? Brazil, Russia, India, and China (BRIC) will likely continue to have a significant impact on biopharma manufacturing over the next several years. As the pharma market has flattened in the U.S. and many EU countries, the BRIC market has thrived due to improved standards of living, more citizens with access to health coverage, and an increased need for medicines related to noncommunicable diseases (e.g., diabetes, cancer, and cardiovascular problems). Pharmaceutical sales have doubled in these markets over the last five years, and projections show continued growth through 2020. Additionally, BRIC nations are looking at biosimilars as their chance to compete for a bigger chunk of the global pharmaceutical market. Many pharma companies have moved manufacturing locally or have partnered with companies in BRIC nations to improve access for their products, while also achieving more cost-effective and efficient supply. This has posed some challenges to industry, as GMP manufacturing expertise and the infrastructure in these markets have struggled to keep pace with the high demand. The companies that are most successful in meeting these challenges will reap the biggest rewards. WHAT NONBIOPHARMA MANUFACTURERS WILL HAVE THE BIGGEST IMPACT ON THE INDUSTRY’S MANUFACTURING IN THE NEXT THREE TO FIVE YEARS? Those working in the areas of artificial intelligence (AI) and robot manufacturing will have the biggest impact. This trend has been growing and will become more prevalent as biopharma manufacturers eventually have most of their tasks conducted through automated systems (i.e., even more than we do currently). Robots will conduct testing on production lines, enter results, and even conduct dual-quality checks. This trend already has been used in various other industries (e.g., automotive and electronics), and the cost savings are significant. Pharmaceutical companies will likely follow this trend and invest more in automation and robots and, in turn, move their human capital toward innovation vs. manufacturing. The advantages of complete robot manufacturing are evident: Errors are reduced, contamination limited, and overall assurance of a repetitious manufacturing process becomes more reliable.

WHAT’S GOING TO BE BIG IN BIOPHARMA MANUFACTURING IN 2018?

Esteban Santos EVP Operations Amgen Clearly, the impact of Hurricane Maria on Puerto Rico and the importance of risk-mitigation and business-continuity strategies will be a topic of discussion in the biopharma industry well into 2018. After an event of this magnitude, the relevance of having well-rehearsed crisis-management and business-continuity plans rises to the top of everyone’s list. Hurricane Maria tested the resilience of our industry’s global supply chain, and from the lessons learned, industry needs to consider what improvements are to be made.

WHAT ARE YOU DOING THAT WILL HAVE A BIG IMPACT ON YOUR MANUFACTURING ORGANIZATION IN 2018 AND BEYOND?

Michael Thien SVP & Head Biologics & Sterile Operating Unit Merck Investing in the infrastructure necessary to explore new processing and analytical technologies is a top priority. In order to define the technology/process of the future, investment is needed now to determine the selection of “intensification strategy.” Factors being considered include existing manufacturing capacity, prior knowledge of existing technologies, size of company and portfolio, potential market for the product, and the stage of product lifecycle. The impact of the selected technology will then be weighed against the risk of successful implementation.

Areas of focused innovation include process intensification, chemically defined simplified media, robust scalable harvest technologies, standardized modular approaches, and single-use technologies. L

G O B E Y O N D Break from the traditional news cycle. Discover the stories that lie beyond the headlines, stock price speculations, and merger announcements.

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EXCLUSIVE LIFE SCIENCE FEATURE

By R. Wright

Leaders

SANAT CHATTOPADHYAY — SHAPING MERCK’S MANUFACTURING FUTURE

Shaping Merck’s Manufacturing Future R O B W R I G H T Chief Editor

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anat Chattopadhyay knows what it is like to face difficult tasks in the biopharma industry. When he was just 30 years old he was tapped to be the CEO of a small, wholly owned subsidiary of Hoechst Pharmaceuticals, India, engaged in manufacturing and selling of semisynthetic beta lactum antibiotics. The company wasn’t doing well, but he was expected to create something that he would be asked for over and over during his future career — a transformational turnaround. “To return the company to profitable growth in the shortest period of time, I knew that I needed a new team,” he recollects. “But with the current state of the company, it was difficult to motivate and recruit more talented leaders. I quickly learned the importance of earning the confidence of others, and I gained a deep understanding of the value of humility.” Fast forward to April 2016 when Chattopadhyay was named president of Merck* Manufacturing Division (MMD) and an EVP on the Big Pharma’s executive committee. He’s learned a lot in between that first CEO job and now, and we were lucky to sit down with him to hear some of the stories that have shaped him as a leader and prepared him for his current transformational turnaround challenge — reshaping MMD to be ready for its biopharmaceutical manufacturing future.

With Every Challenge Comes A New Lesson Learned

While still at Hoechst, Chattopadhyay experienced a series of mergers and company restructurings (i.e., Hoechst Roussel merger with Marion Merrell Dow, which later merged with Rhône-Poulenc Rorer to form Aventis, and eventually Sanofi). While at Hoechst Marion Roussel, as the head of Indian subcontinent manufacturing operations, he had the opportunity to restructure the company’s manufacturing footprint which consisted of five sites and about 4,500 employees. Oh, and do so while reducing costs and improving gross margins. “We ended up closing most of the sites, reduced the workforce by 70 percent, and radically expanded our external manufacturing capabilities,” he recalls.

In addition to contracting with about 50 CMOs, Chattopadhyay says the company also embarked on building a new greenfield manufacturing site. It was a complex and stressful experience that further honed his leadership chops — especially in terms of talent management. “I also learned how to negotiate with a very aggressive unionized workforce.” In his next position as head of manufacturing operations at Aventis Europe, he learned an important tenet of biopharmaceutical manufacturing leadership. “Senior manufacturing leaders should not only solve problems when they occur, but be able to sniff out the glitches before they happen,” he says. “Very often, supply is interrupted by a variety of technical issues in quality and compliance or in process and analytical robustness.” The better a leader is at doing Failure Mode Effect Analysis (FMEA) of business operations, the better they will be at understanding the single points of failure — and the less likely they will be surprised by unexpected manufacturing interruptions. “One of the best ways for manufacturing leaders to help their organizations is to become champions of the unsung ‘fire prevention’ heroes.”

Understanding Manufacturing’s Role

Those past positions led to him being hired at Wyeth where, after a few years, he was put in charge of transforming the company’s commercialization organization. Although this experience was similar to those past projects, he calls it “a defining moment” in his career. “In a research-driven pharmaceutical company, it is clear that the R&D enterprise creates value by building a company’s pipeline,” he states. “Marketing enhances that value by building brand equity through market penetration and expansion. I didn’t fully understand either of these concepts until I was at Wyeth.” With this challenge, he earned a much deeper understanding of the role played by each of a company’s organizations/ divisions and how they need to work together. He even earned greater insight into his own discipline. “Manufacturing’s role is all about value preservation,” he explains. “Ensuring the best manufacturing quality, compliance, and supply at a competitive cost prevents disrupting and eroding all the value and trust created by the R&D and marketing sides of the business.” LIFESCIENCELEADER.COM

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A Difficult Balancing Act

SANAT CHATTOPADHYAY — SHAPING MERCK’S MANUFACTURING FUTURE

According to Chattopadhyay, failure rates are extremely high for small molecule products to make it all the way to approval. “You have to be very careful about how you invest in manufacturing capabilities because if it is too much too early and the product fails, the write-off could be very high.” Conversely, sometimes between Phases 1 and 3 there can be a dramatic acceleration of timelines resulting from very positive data readouts. Receiving a breakthrough therapy designation from FDA with accelerated approval timelines requires having a very speedy product launch capability. While at Wyeth, to deal with such a balancing act, Chattopadhyay tried a few things. First, they tried to outsource post-Phase 2b process development activities to variabilize costs along with establishment of in vitro/in vivo correlation to develop and optimize drug formulations. Then they focused on solid-phase chemistry, namely crystallization, in order to create the right particle size that allowed for the most forgiving formulation designs for broader specification for dissolution. Such

approaches helped to improve agility and speed with developing process and analytical robustness for the launch of new small molecule products.

Merck Vaccines — A Lesson Learned The Hard Way

When Chattopadhyay was hired by Merck in November 2009, he was given the challenge of transforming vaccine manufacturing and supply. Success in the previous few years, namely the launch of four new vaccines (i.e., GARDASIL, RotaTeq, ProQuad, and ZOSTAVAX) had made Merck the largest vaccine company in 2007. But the overnight success also created a gap between its value creation (i.e., R&D) and value preservation engines (i.e., manufacturing). That gap had caused a succession of technical problems. From 2007 through 2010 the company experienced frequent supply interruptions and prolonged stock-outs of its vaccines, which was reflected in the FDA’s drug shortage listing. There were recalls (i.e., 1.2 million doses of pediatric

In the last 10 years there has been tremendous focus in Big Pharma on restructuring. “Companies were primarily looking to reduce the size of their manufacturing footprint with an outcome of reducing the conversion cost,” explains Sanat Chattopadhyay, president of the Merck Manufacturing Division (MMD). “The conversion cost is basically the value-added cost.” Thus, if a company reduces the number of its internal manufacturing sites, it reduces the number of people, thereby lowering its conversion cost and improves the network capacity utilization. “Whether it's product life cycle management, improving a product’s gross margin, enabling speed to market, or any of the things that can make a meaningful improvement in profitable growth, the biopharmaceutical world has been captivated by the thesis of attacking primarily the conversion cost, which is best achieved through outsourcing and/or low-cost country sourcing.” Chattopadhyay believes this trend resulted from companies not looking for other ways to reduce cost of goods sold. By closing down a few manufacturing sites, companies were able to not only reduce their fixed costs, but convert some of what was left to a variable cost via outsourcing. “But we didn’t pause, think, and explore what companies in other industries were doing to try to reduce costs,” Chattopadhyay says. “A manufactured pharmaceutical tablet is essentially 80 percent

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material cost and only 20 percent conversion cost, on an end-to-end basis. Why are we so focused on attacking the smaller of the two percentages?” He feels biopharmaceutical companies need to consider deploying new technology platforms, innovation in manufacturing and analytical processes, and other means (single-use technology, etc.) by which they can reduce the 80 percent material cost and radically improve gross margins. “In biologics, there are examples of companies creating massive plants only to end up mothballing them for many years because the company was able to increase the yield of a manufacturing process so astronomically that they were able to be much more efficient on a much smaller manufacturing footprint.” With cell lines capable of yielding >40 gms/lts titer, one can try to grow the cell mass continuously and crystallize the antibodies also continuously to drastically reduce the cost of monoclonal antibodies to < $10/gm, for both small and large volumes, depending on whether it is an acute care or a chronic therapy product — that is the kind of future the pharma industry should gear up to create. While it is more common to have such surprises in biologic processes, Chattopadhyay feels companies should not ignore trying to make process improvements in small molecule manufacturing. He is not alone. Frank Gupton, Ph.D., a former pharmaceutical manufacturing

vaccines) and numerous supply interruptions for its shingles vaccine ZOSTAVAX. At all of those previous companies, Chattopadhyay noticed that much of the success for those transformation projects depended on talent management, talent recruitment, and team creation. And at Merck he knew there was a tremendous amount of preexisting technical talent. “What we lacked was a few leaders with deep vaccine manufacturing operations experience,” he says. “So, while I built on the great foundation given by my predecessor, most importantly I also hired some enormously talented leaders and tasked them with getting the best from the people we already had.” The leaders were given some autonomy on how to best achieve the goals of the initiative, and one manager opted to use the book QBQ! The Question Behind the Question: Practicing Personal Accountability at Work and in Life by John Miller. The book was used to help communicate Chattopadhyay’s leadership philosophy of personal accountability. At Merck’s Pennsylvania West Point vaccine manufacturing facility, at least 400 copies were distributed to team members. “By the end of 2012, we had a very different face, and all of the vaccine shortages had practically vanished from the FDA website,” Chattopadhyay concludes.

executive turned professor at Virginia Commonwealth University (VCU), has been exploring how to do this very thing through the Medicines for All Initiative (M4All), a project supported by the Bill and Melinda Gates Foundation and the Clinton Health Access Initiative (CHAI). According to Gupton, the cost of producing a wide range of pharmaceutical products is higher than it needs to be, particularly in the area of APIs, which make up 60 to 70 percent of a drug’s cost. But the initiative is also looking at reducing costs in starting materials and pharmaceutical manufacturing processes. Thus far the project has achieved dramatic yield improvements, waste minimizations, and cost reductions for three high-volume HIV drugs. Outside of Gupton’s work, Chattopadhyay believes the focus on product and process improvement tends to be much more prevalent in countries such as China and India. “In the United States, we are too intoxicated with the concept of reducing the conversion cost via outsourcing,” he says. “I expect this trend to change as people realize the limitations of this as a means of reducing the conversion cost.” Since a huge amount of the site closures have already happened, companies will be looking for other means to reduce costs. Questions being explored at MMD to reduce material and manufacturing costs (i.e., non-conversion costs) include: ▶▶ Is there a way for us to redefine MMD’s starting materials?

He says 99 percent of the Merck vaccine and manufacturing operations talent remained unchanged during the transformation. So, there was no need to “slash and burn” to achieve success of this magnitude. “The new leaders were great at reminding everyone after the transformation not to give credit to the newcomers, but to congratulate those doing the work,” he explains. “After all, these were the same people who had done the work in the past, only now they were reporting to new leaders.”

Avoiding The Manufacturing Challenges Of The Past

Like many of the iconic pharma companies that have traditionally focused on small molecule drugs, Merck is becoming more biologically focused (e.g., KEYTRUDA). As such, it’s up to Chattopadhyay to make sure MMD’s biologic manufacturing capabilities don’t suffer from the same challenges that affected its vaccines division.

▶▶ Is there a way for us to reduce the total number of synthesis steps? ▶▶ Is there a way for us to reduce the input per unit output and improve yield? ▶▶ Can we create standard technology platforms so the cost base becomes much different, regardless of the product’s life cycle? ▶▶ Can we achieve high levels of quality and compliance with lower levels of investment (i.e., standardization)? “Many of the concepts we are investigating (e.g., combinations of lean capabilities, novel ways of looking at technology platforms, adaptive formulation, and filling technologies) will not only enable speed and flexibility at low cost, but become commonplace in industry,” Chattopadhyay affirms. “The advanced analytics are getting leveraged a lot more to improve production yield and reliability.” As such, Chattopadhyay expects the following manufacturing support areas to experience significant growth: rapid micro methods, sterility testing, mass spectroscopy (MS), Raman spectrometry, nano screening, ultra-performance liquid chromatography (UPLC) for extended characterization of biologics, and various raw-materials screening devices. “The manufacturing industry of pharma will look a lot different in the future, as the concepts of miniaturization, continuous manufacturing, and single-use systems (SUS) become commonplace,” he concludes.

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If Merck R&D continues to deliver results, Chattopadhyay believes MMD can ensure access to these therapies only if it achieves the following: ▶▶ Has the highest quality at the lowest cost, with the shortest lead times

SANAT CHATTOPADHYAY — SHAPING MERCK’S MANUFACTURING FUTURE

▶▶ Is a top quartile performer in cost of goods sold, working capital, and compliance ▶▶ Is an industrial leader in speed to market with flawless new product launches ▶▶ Has a best-in-class talent reservoir. “This is our manufacture-the-future model, which was previewed in October 2015 and then formally rolled out in October 2016,” he shares. The strategy is all about compliance, supply, profit plan, and people — four elements that should remain constant for nearly every biopharmaceutical company’s manufacturing division.

The Five Pillars of MMD’s Strategy There are five pillars of Chattopadhyay’s MMD transformation strategy: stability, responsiveness, innovation, biologics, and talent diversity. “For me, stability is number one because we want to have the mindset of safety first and quality always, which go hand in hand. As a pharmaceutical manufacturer, if you cannot guarantee the safety of your employees or the quality of the product to the consumer, then you should be in another business,” he advises.

MMD is aiming for very high standards of compliance, including top-quartile performance in on-time-in-full (OTIF) and line-item-fill-rate (LIFR) greater than 98 to 99 percent, right-first-time of 85 to 95 percent, with zero market actions and zero safety incidents. In 2015, the division installed a “Safe by Choice” program to build accountability, conviction, and commitment into every MMD employee. “We’re creating extreme vigilance and remediation in high-risk areas (e.g., hazardous energy, spillage of solvents, confined areas),” he explains. “A focus on safety will create a very high right-first-time attitude, minimize recalls, redefine inspection excellence, and improve customer service.”

MMD is striving to be in the top quartile in terms of cost of goods sold and inventory. “To do this we need to become much more agile, which will be evidenced by end-to-end lead-time reduction,” he states. “As for

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speed to market, we will have to be enormously good at this because we are looking at a large number of potential breakthrough therapies in the pipeline, and you cannot underestimate the advantage of being the early mover.”

Chattopadhyay expects technology platforms to change dramatically in the future and continuous manufacturing to become more pervasive. “The future will belong to small, agile, and modular formulation facilities that can produce four times more volume at a fraction of existing setup and changeover times — and do so for even one batch.” He believes such changes will crash direct costs and lead times while also changing the competitive field, especially the difference in capital and conversion cost between the western economies and India and China.

This pillar has its roots in the highly successful clinical trials for KEYTRUDA in 2012. The company needed to create a robust manufacturing process for a monoclonal antibody in lyophilized formulation in less than 24 months — “which was a huge challenge for Merck,” Chattopadhyay notes. Still, the product was successfully launched in 2014 and is expected to generate between $6 and $8 billion by the year 2020. “In KEYTRUDA we have more than 500 clinical trials in 32 different tumors with more than 60 mono and combo therapies involving more than 8,500 patients. That’s why biologics is an MMD strategic pillar.”

Shifting MMD toward a biologics culture requires a new kind of mindset that is focused on developing a long-term biologics network. “For example, we are working on mammalian cell culture and striving to develop high-titer product that can get produced in single-use systems (SUS) in a modular format so we can continuously grow the cell mass very high and continuously crystallize those antibodies,” Chattopadhyay explains. “To do all this we need to change the paradigms of talent diversity at MMD, not just skill diversity, but gender and generational diversity as well.” Like any seasoned biopharma industry veteran, Chattopadhyay knows his days of facing seemingly insurmountable challenges are far from over. This is a fickle and constantly changing industry where transformational turnarounds are inevitable. Luckily for Merck, with Chattopadhyay at the helm of this $40 billion enterprise, they have a leader who is not only up for the challenge, but also well prepared for it. L

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SUCCESSFUL TRANSFORMATIONS REQUIRE A POST-PERIOD OF REFLECTION

R O B W R I G H T Chief Editor

By R. Wright

Successful Transformations Require A Post-Period Of Reflection Editor’s Note: Sanat Chattopadhyay is the subject of the cover feature in Life Science Leader’s August 2017 issue. The president of Merck Manufacturing Division (MMD) sat down with us to share stories that shaped him as a leader and prepared him for his current transformational turnaround challenge of reshaping MMD to be ready for its biological manufacturing future. The below article was originally put together as a prequel to that feature article.

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hile it is a little early in the Merck Manufacturing Division (MMD) transformation to determine what, if anything, he would have done differently, it is likely Sanat Chattopadhyay will explore this exercise in the near future. “Every time I complete an assignment, whether a transformation or consolidation, I reflect on what was done and realize that there are always some missteps,” shares Chattopadhyay, the president of MMD. “For example, when I was in India, I did the transformation from internal to external manufacturing too fast. Sometime I could benefit from right-sizing my own ambition,” he says with a smile. A second learning he has experienced during reflection involves talent management. “From a leadership perspective, it is very difficult to find the balance of when it is appropriate to replace an individual with a better version. If you have grown with an individual, you create a loyalty that can be difficult to overcome, resulting in lost objectivity.” To overcome this, Chattopadhyay tries surrounding himself with a group of leaders who help him remain objective on critical senior talent-management positions.

If I don’t understand the products well, I can’t lead manufacturing well. “If I don’t understand the products well, I can’t lead manufacturing well.” This is a statement he made after pondering a third area of reflection. “I’ve always been pretty good at bringing an outside-in understanding to my roles. But sometimes, even today, I can get caught up in ‘firefighting’ mode and fail to spend enough time with R&D and marketing — critical areas that help me better execute my job.”

But there are other learnings. “One of the first things I learned early in my career is the importance of creating a vision before embarking on a transformation,” he explains. “Then, you need to focus on the critical few things that are necessary to achieve the mission.” Chattopadhyay also believes organizations always respond best when they know what and how to prioritize to drive flawless execution of a strategic roadmap. In addition, he feels it is best to be a high-demand, high-support leader. “It is okay to be demanding when leading, but you also have to be supportive and empathetic,” he states. “You have to care about your employees, for those are the ones who make things happen every day.” High demand and high support go hand in hand to get the best out of an organization. Finally, it should go without saying that Chattopadhyay learns a lot from the leaders he surrounds himself with. “I have always tried to recruit leaders who are better than me in areas where I have gaps,” he says. “It may sound cliché, but having people who know more than you, working for you, forces one to up their game every day.” But beyond this, Chattopadhyay says he doesn’t try to necessarily recruit just leaders, but rather, leadership teams. “When you are recruiting/building a team, if you want to get the best out of them, you need to not only compensate for the weaknesses, but have folks who can operate well collectively.” But you won’t be successful at doing any of these things if you don’t first take the time to understand yourself as a leader. “Great leaders are like a conductor of a complex orchestra. They can’t play any instrument better than its members, but they know how to compose and create an environment that gets the best out of them at the right times,” he concludes. L LIFESCIENCELEADER.COM

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G S K M A N U FA C T U R I N G

GSK MANUFACTURING — ENABLING CULTURAL DEVELOPMENT AT THE SITE LEVEL

ENA BL ING C ULTU R A L D EVELO P M ENT AT T H E SITE L E V E L R O B W R I G H T Chief Editor

◀ Michael Szymanski, Site Director, GSK Marietta, PA

t is summer, and today, exceptionally hot. It is also peak flu vaccine manufacturing season, and I have been given a rare opportunity to tour the 90-acre GSK vaccine manufacturing facility located in the small town of Marietta, PA (population about 2,700). Acquired by GSK from Wyeth in 2005, the 132-year-old site underwent a five-year, $375 million upgrade prior to resuming operations in 2009. My tour guide is the facility’s site leader, Michael Szymanski, who, having completed his master’s degree in quality engineering down the road at Lehigh University, is probably considered a “local.” As we walk the campus, Szymanski patiently explains various manufacturing concepts such as rouging, (i.e., a thin deposit often found on mirror-finished stainless-steel surfaces which line containers storing highly purified water). His knowledge of the various plant processes seems unparalleled, as is his familiarity with his facility. For as we walk in and out of buildings, Szymanski greets employees (of which there are about 250) by their first name. Soon we are seated in the coolness of a glass-walled

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meeting area located at the end of a large open-office space in building 40, to conduct our interview. As we talk, I am surprised to learn that despite the world of biopharmaceutical manufacturing being highly-standardized, GSK doesn’t take a similar “one-size-fits-all” approach to managing the culture of its globally dispersed manufacturing sites.

CHALLENGES OF MARIETTA — NOT SOLVED IN A VACUUM

As Marietta is part of GSK’s 16-facility global vaccine manufacturing network, Szymanski is encouraged to exchange ideas with his fellow site heads. For example, the Marietta facility was working on a project to complete its annual routine restart of its adjuvant manufacturing process. “We have a sister site in France that has a manufacturing skid nearly identical to ours, and they were working through some similar process issues,”

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he explains. While in Belgium for some site-leadership meetings, he struck up a conversation with the new site director for the France facility, Gael Ruche. “I suggested that I’d like to spend a day at the site,” he shares. “I wanted to work with their lead team to see how they were doing things and perhaps steal a few ideas to bring back to Marietta.” While touring the French facility, Szymanski realized their two sites had a lot of common challenges.. Ruche was explaining his next manufacturing campaign and supply commitment when Szymanski got an idea. Right before the French facility was planning to start that new manufacturing campaign, the Marietta plant would be in its summer shutdown period. This shutdown happens every year to complete significant maintenance activities to all systems that support aseptic manufacturing processes that cannot be done during manufacturing periods. Szymanski suggested sending some of his team to France during this time to help with training, share best practices, and maybe solve some of their common problems. Ruche was all in. “We ended up sending two people [Scott Haberstroh, manufacturing support supervisor and adjuvant manufacturing operation leader, and John Jenkins, manufacturing support and adjuvant manufacturing operator] to work directly on the shop floor with their French counterparts for two weeks. They shared some of the challenges we had, as well as some of the solutions developed. Ultimately, this exchange of information helped improve both site’s process.” When the team returned, they put together a trip report detailing their key learnings and takeaways. “Our Marietta leadership team then used that information when making future decisions related to similar issues. Manufacturing is a complex pro-

cess that is always improving as new technologies become available and at GSK one of our commitments is to continuous improvement” Szymanski says. Now you might be wondering if such an exchange requires upper management/sponsor approval. The answer is no. “We are organized to drive collaboration between sites that are doing the same thing,” Szymanski says. “We want to avoid making the same mistakes at different sites over and over again. ” Solving challenges at the site level, and then transparently sharing best practices throughout GSK’s manufacturing network is a senior-level directive. However, proper execution requires site-level autonomy. According to Szymanski, over the 11 year history that Marietta has been part of GSK, the site has sent people to other locations for learning and development and had employees from other sites come to his facility for similar experiences. “The employee exchange program has made Marietta a stronger manufacturing location,” he asserts. But perhaps it isn’t the employee exchange that has made Marietta better, but a culture that encourages the exchange of feedback.

THE GIFT OF FEEDBACK CULTURE

“Getting people and leaders comfortable giving and receiving routine feedback is not only a key element of leadership development, but it’s critical to creating a high-performing team,” contends Szymanski. “Feedback can be either corrective or confirming. And while it doesn’t necessarily need to happen every day, or even every week, it needs to happen.” Every Marietta employ-

A project management working document spans almost the entire hallway where Michael Szymanski stands at GSK’s Marietta, PA plant.

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GSK MANUFACTURING — ENABLING CULTURAL DEVELOPMENT AT THE SITE LEVEL

By R. Wright

ee is required to meet with a direct supervisor three times a year (beginning, middle, and end) as part of their annual personal development plan. But Szymanski says even that’s not enough; you’ve got to have a feedback culture. Because while it is easy to say “thank you” or “good job,” telling someone they are not meeting expectations is often difficult. “This is why many people tend to avoid giving corrective feedback,” he shares. “For a leader to be good at giving feedback requires not only being comfortable in doing so, but having a competency and understanding of when to be directive, versus mentoring, versus coaching.” Marietta’s quality lead, Chris Savitz, and representatives at three to four other GSK sites developed some training tools related to giving and receiving of feedback. “We put together some videos with a popup box that looks like a little gift box (i.e., the gift of feedback) that gives some tips for how to be ready to receive or give feedback to create the proper mindset.” Another feedback tool developed by Marietta is what they refer to as “our game plan.” “It’s based on our MOST (mission, objectives, strategies, and tactics), framework,” Szymanski elaborates. On a quarterly basis, the Marietta management team reviews the game plan and updates the tactics to target what they need to do to be able to deliver. Every employee is given a game plan card, which may be worn on the same lanyard as their GSK ID (see image on next page). It details the mission for the site (i.e., why we exist), the objectives (i.e., what we aim to do), strategies (i.e., how we will get there), and tactics (i.e., what we need to do first). Szymanski views this MOST card as another means to drive the feedback conversation. “From the management team to their direct reports, from supervisors to employees, this is what we need to be working on, where we are doing a good job, or where we need improvement.” The Marietta site game plan and the MOST card were developed by and specific to the staff at that plant. “These work in our culture, and my site management counterparts have tools and techniques that work in their cultures.” And while Szymanski believes these tools have helped create a more engaged Marietta employee environment, that wasn’t always the case.

WANT ENGAGED EMPLOYEES?

A few years ago, Szymanski and his leadership team were working to understand the level of employee engagement. “We had some corporate top-down surveys that were administered across the entire organization that asked a whole bunch of questions,” he says. “We were surprised by scores indicating our employees weren’t very engaged in their work.” In response, the

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Q3 2017 MARIETTA SITE GAMEPLAN

THE DIFFERENCE BETWEEN STRETCH AND STRAIN Any athlete knows the difference between stretch and strain. But such insight should not be left to those who compete in arenas. “As a leader, we want to understand and work with our teams to stretch them,” Michael Szymanski explains. In the business world, some level of stretch is certainly healthy. “But when you move beyond stretch into strain, you are setting everything up to fall like dominos,” assures the GSK vaccine manufacturing site director. “For it is only a matter of time that a person makes a mistake, a system fails, you have an injury, you have a batch rejection, or something even more significant.” Szymanski says we have probably all made stretch versus strain mistakes at some point in our careers. But we can avoid doing so in the future by having a deep understanding of what our team’s capabilities are, and having conversations with the team about them. “If you and the team recognize when you are moving into strain, you can pull back to a point that is more comfortable, while still being able to deliver,” he states.

Key to sustainable performance = Oscillate between stretch & comfort

Strain

Stretch

Comfort

Boredom

Low

Overwhelmed

Fatigue, poor judgment, poor decision making

PERFORMANCE

High

As a new supervisor, Szymanski admits the concept of stretch versus strain would probably have been lost on him. “I come from a family background of hard work, long hours, and doing what is expected,” he says. But as the business environment has evolved, so too have values and motivations for people in our society. “We talk a lot about stretch versus strain at the site leadership team Zone of level, and it’s an element of the GSK coaching process, Delusion Optimum performance and Marietta’s personal resilience training,” he adds. when you’re here

Minimum

Average

Maximum

RUST OUT

LEVEL OF PRESSURE

BURN OUT

Exhaustion, serious health problems, breakdown, burnout

Marietta leadership team brought in a consultant that used a Gallup survey tool to further assess employee engagement. Although there were five questions to the survey, Szymanski says it was the first two that were the most important: “Do you know what you need to do in your job?” and “Do you have the resources to do what you need to do?” “The science says that if the employee understands what they need to do, and they have the right resources, they’ll be engaged to deliver on their job.” The Marietta leadership team began using the Gallup survey questions in their one-on-ones with employees. The MOST concept would eventually evolve out of this practice. They also used it as a way to link corporate strategies into something meaningful to people on the shop floor. For example, he and his finance controller and supply chain manager put together a quarterly financial review for the site. “We link what we are doing at Marietta to what is happening in the vaccines business and GSK overall, by tying our information to corporate

“To be able to manage your team and not have a negative impact on them, you need to first understand your own level of personal energy, as well as how you react/handle things,” he advises. “This needs to be combined with what you think employees are able to deliver when asked, while also trying to take into account the things you don’t know (e.g., what an employee might be dealing with in their personal life).” (The left curve visually illustrates the stretch versus concept). “Understanding when people can and cannot do more is pretty important for a manufacturing site leader,” he concludes.

quarterly reports,” he explains. By taking this approach, Szymanski feels shop-floor employees are better able to see how a rejected batch or an on-time delivery impact the global vaccine business and GSK overall. “The challenges we have around engagement are more internally focused, such as a third-shift employee understanding why what they do on a Sunday night is important to Marietta and GSK.” To address this requires Szymanski not doing just one town hall meeting, but town halls across all the shifts, as well as using many types of communication modes (email, plasma screens, and posters). “The other thing I’ve done is to meet with small groups of employees on a routine basis — across all shifts and functions,” he shares. In addition, Szymanski has routine shop-floor visits (i.e., Gemba walks) and informal meetings around coffee or lunch. “Those are the kinds of things that really help drive engagement at the site, as well as our tiered accountability process that uses visual factories (i.e., strategically placed whiteboards) so people can understand where we are winning LIFESCIENCELEADER.COM

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By R. Wright

Leaders

GSK MANUFACTURING — ENABLING CULTURAL DEVELOPMENT AT THE SITE LEVEL

◀ Chief Editor Rob Wright (left) on the tour of GSK’s vaccine manufacturing facility along with the facility’s site director Michael Szymanski

or losing, if we are on or off our target, if we have a problem, and who is taking action, and when.” Szymanski says being highly and visibly transparent are the real drivers behind Marietta employee engagement and performance, which, as of this writing, includes an RIIR (i.e., a measure of reportable incidents and illnesses) of 0 for the past 12 months. But there is another aspect that drives engagement at Marietta.

MARIETTA ONE TEAM — A CULTURE WITHIN A CULTURE

At GSK’s Marietta site, they have developed a “oneteam” mentality. “It’s the idea that if everyone on the site is accountable to take action for the benefit of the site, we will all be very successful,” explains Szymanski. “One team” came about when he and his site leadership team began to see the development of a silo mentality between the packaging and FFL [formulation, filling, and lyophilization] organizations. “By design, these two are not linked at Marietta, and neither supplies the other,” he elaborates. “But that does not mean they should work in silos and avoid interacting with one another (i.e., siloed).” Szymanski and his leadership team felt that the better everyone at the site knew each other, the better they would be able to help one another, thereby helping the plant overall. Szymanski walks over to a poster on a wall and begins to explain. “Near the poster you see various GSK corporate values — T-R-I-P — transparency, respect for people, integrity, and patient-focused,” he shares. “These create a framework for employees in their day to day business decisions, and provide a good foundation.” But Szymanski felt Marietta needed something more, to help site employees translate how these corporate values fit into what they do every day, while also removing silos. Pointing to the poster he continues. “On the right hand side are GSK expectations. On the left hand side is a center circle, surrounded by twelve smaller circles, like a clock.” The center circle has Marietta’s definition of one team. “Everyone feels compelled to take action for the performance of the whole site,” he states without looking at the poster. “Then we have different examples in the smaller outer circles of what we, as an extended

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leadership team, want, in giving and receiving of feedback.” For example, drive decisions to the right level. “I don’t need and can’t take every decision on-site,” he explains. “If we continually escalate decision making beyond where it needs to be, the business will slow down.” The “one team” poster serves as a reminder and teaching tool for the site-level culture Marietta is striving to achieve, and intended to help employees make better decisions. Szymanski refers to the 12 circles, and the ideas within, as JDIs (i.e., just do it). “When supervisors and managers are having conversations with employees, or even peer to peer, JDIs are a common language to help people give the gift of feedback,” he reaffirms. “Everything is linked back to the Marietta One Team JDIs, including rewards and recognition (e.g., thank you cards, cash).” He concludes his poster explanation noting that working at GSK’s Marietta facility involves a lot of ands. “We need to be focused on safety and quality and cost and supply,” he concludes. “But as a leader, we need to take decisions and prioritize in the moment (i.e., safety first, quality always, then supply, then cost), and the one team approach helps everyone communicate that more clearly here at Marietta.” L

THE POWER OF WOO Michael Szymanski, site director for GSK’s vaccine manufacturing facility in Marietta, PA, is a microbiologist by training. “Leave me alone with my microscope,” he laughs, noting this is likely the perception most people have of scientists. “But I get personal energy from meeting and talking with people.” One of the tools GSK uses to find attributes like Szymanski’s desire to engage with employees is a Gallup poll called strength finder. “It is a personality assessment tool, similar to Meyers-Briggs,” he explains. “You answer a couple hundred questions and it tells you your five top strengths.” Szymanski’s top strengths are arranger, learner, communicator, problem solver, and WOO, which stands for winning others over. “Strength finder is the one I like most, because WOO really describes me,” he affirms. While Szymanski admits there are some new people whose names he doesn’t yet know, he feels he’ll get there, by engaging, asking questions, and playing to his strength of WOO.

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OPERATIONS

By R. Wright

Not Your Typical Biopharma Manufacturing Career Path

NOT YOUR TYPICAL BIOPHARMA MANUFACTURING CAREER PATH

R O B W R I G H T Chief Editor

@RfwrightLSL

Michael Szymanski’s career path has been anything but typical. He started in a quality function and rose to his current position as site director for GSK’s vaccine manufacturing facility in Marietta, PA. “Today, a background in quality has become a competitive advantage, so my career path may not be so unusual in the future,” he explains. “Understanding regulations and how we can use QA to help achieve our business objectives have been a big help to me in my career.” He adds that running a quality control operation is similar to running a factory; it has inputs, raw materials, processes, outputs, lead times, and productivity measures. Having that experience also was helpful when he moved into operations management.

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nce he became a site director, he had to to navigate the tricky situation of supervising many of his peers whom he had worked alongside recently. He also had to learn to go from operating at a mastery level of expertise to starting that journey all over again. “As a beginner, you have to learn things at a much deeper level to understand the organization’s financial processes, and all the EH&S [environmental, health, and safety] things going on,” he says. Probably his biggest challenge, though, was, “You need to be absolutely comfortable and ready to say ‘no’ to senior management.”

EVER HAVE TO SAY NO TO YOUR BOSS? The first time Szymanski had to say ‘no’ to his boss involved managing a demand forecast in a supply situation. “We were looking at what we were producing in our sterile production facility, in the FFL [formulation, filling, and lyophilization] organization. We noticed that, in the short term, we were going to be below our safety stocks and inventory, and there was a request to increase production to address that.” This was early in the facility’s startup of aseptic operations, and the site was still in the process of hiring and training people to fully build out all three work shifts toward ramping up production. “There was a strong push to deliv-

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er that volume,” he recalls. “I had to say no, as we were not ready, and even if we did attempt to deliver on the request, we would not have been able to meet the time frame.” Szymanski pointed out that just attempting to do so may have resulted in quality issues or rejected batches. “That was not the right thing to do for the business,” he surmises. This was counterintuitive to typical site director thinking. “You want volume, because that’s what makes your site sustainable,” he states. “Having to say no in such a situation is really difficult.” But Szymanski says the answer is never just “no.” “It was no because of where we were on the previously agreed upon recruiting plan,” he notes. The site director informed his superiors as to where the facility was regarding training, where he thought he might be able to accelerate, and by what date the facility would be capable of delivering a specific volume. “Instead of just saying, ’No, I can’t do it,’ it was explaining why, to the best of my ability, and then negotiating to find a different solution,” Szymanski explains. Finding solutions required reaching out to other parts of the organization (i.e., folks responsible for manufacturing outsourcing) and asking if it was possible to move some of the needed manufacturing to a CMO. “The reason why saying ‘no’ wasn’t a career-ending moment was bringing other options into the conversation,” he concludes. L

outsourcing

CDMO PARTNERSHIPS

By R. Wright

You Can Do Everything Right, But Still Get Burned By Outsourcing

CONSENT DECREES AND OTHER FORMATIVE SITE-LEADERSHIP EXPERIENCES

L O U I S G A R G U I L O Chief Editor, Outsourced Pharma

@Louis_Garguilo

Literally, get burned. This is a narrative of how a virtual biotech did everything in its power to execute on an outsourcing strategy, but still suffered a critical setback at its service provider. Two points need to be made up front before we hear firsthand from Aequor’s CEO, Marilyn Bruno.

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irst, Aequor has recovered from the setback you’ll soon learn of, and the company is doing well. Second, this is not a tale told to ward off U.S. companies from outsourcing to India (or any other overseas locations), but it certainly is a warning about outsourcing risk in general, and the risk geography can present in particular.

THE FIRE Aequor, a San Diego-based virtual company founded in 2006, focuses on developing small molecules that prevent bacteria and fungi to form biofilm, which is a cause of contamination and infection. The company has received wide recognition, and vital financial grants from the USDA, DOE, NIH and DOD, and this year a NASA Space Flight Center started testing several Aequor molecules onboard the International Space Station. Aequor research and development on molecules funded by U.S. agencies requires work be completed in the U.S. The company also has a subsidiary in Europe, and when applying for EU grants, that work is promised to European service providers. For all other R&D, Aequor – like any other drug developer – is free to operate around the world. And as we’ll come to understand, at times it really has no choice but to do so. According to CEO Bruno, in 2016 a service provider in India was highly recommended to Aequor for a specific project it was looking to outsource. “At first,” she recalls, “we thought no, we don’t want to work on this overseas, particularly because all our patents hadn’t been published yet. But the recommendations – some firsthand from a well-known Big Pharma — finally con-

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vinced us this was the best location, and last year in April we started a relationship with that Indian CDMO. The fact is: That CDMO is highly regarded to this day.” The deadline for the deliverables — set by the CDMO — was for September (four months from project start), but was missed. The delay kept extending. “In the meantime, we were forced to hire our own chemists to oversee their work,” says Bruno. “And then came the fire in December.” According to Bruno, a fire caused the destruction of the entire building where Aequor’s work was being conducted, “from all the precursor chemicals to the entire work product.” The CDMO informed Aequor it was “an act of God,” and said they were not liable for the loss. “I had to acquire the police report to see that, in fact, one of their workers had left an uncovered bottle in a hood that had exploded,” explains Bruno. “That was negligence.” Despite informing the CDMO that its negligence was costing Aequor “a great deal of damage and lost opportunity,” and Aequor’s verifying that the CDMO had insurance, to this day the company is still trying to at least get reimbursed. “Unfortunately, as a tiny compa-

I had to acquire the police report to see that, in fact, one of their workers had left an uncovered bottle in a hood that had exploded.

Is there a risk? Yes, but again this was a well-regarded CDMO, working for Big Pharma and many others for years, and yet they failed us, and failed to act in good faith. M A R I LY N B R U N O CEO, Aequor

ny relying on grants that don’t pay for operating capital, we just cannot afford to start litigating in India.” And so, on behalf of anyone looking to outsource — and particularly small organizations — Bruno wants to point out just how critical geography can be. “Where we thought we would be saving money by working with this company, and gaining their rare capabilities, this has not been the case. We paid them all the money that we had earmarked for this work. We now have backup plans — A, B, and C — and learned that outsourcing can come fraught with risk.” She sums up: “While a year ago we were ahead of schedule on these very important programs we won from the NIH and the DOD, and could have tolerated delay of a month or two, we fell way behind in the game.”

DUE DILIGENCE At the beginning of this article I wrote that Aequor did “everything in its power” to execute on its outsourcing strategy. Some might challenge that. Aequor did not fly to India to physically inspect the CDMO, for one thing. And of course, the company could have gone with its original thoughts that India was indeed too far removed from them, and wasn’t a good fit. And while in hindsight those may be valid assertions, there are also undeniable realities that render them just that — hindsight. First, let’s look at the due-diligence aspect. “We adhere to a policy of finding most of our partners through strong referrals,” says Bruno. “We get clear and serious endorsements from who we consider respected advisors, and they provide a history with the service provider that we could not otherwise ascertain. So networking is critical to us in finding the right group to work with. As a small company, we can only aspire to due-diligence processes you might find at Big Pharma, to having the financial and human resources for flying around checking everybody out.”

Bruno continues: “Is there a risk? Yes, but again this was a well-regarded CDMO, working for Big Pharma and many others for years, and yet they failed us, and failed to act in good faith. So, I guess you never know.” What all cutting-edge drug developers do know is that at times during a company’s growth, the choice for service providers can be few, and as they say, far between. Like India and the U.S. “We need to contract the best advisors and specialists in our fields,” says Bruno. “The chemist who referred us particularly to a specialist chemist at the CDMO had the experience of working with his company for five years — and his company spent over $20 million dollars with an excellent track record. But when you’re a small company, any risk is magnified, including the risk of geography. You don’t have the financial cushion or the human resources.” Or, we might add, small companies, an ocean away, don’t have the clout to have righted a project and relationship gone terribly wrong. Nonetheless, Bruno understands what needs to be done to advance Aequor and its pipeline. “Honestly, even today I can say we don’t feel constrained by geography, in the sense that we have to rely on experts for everything we do,” she says. “If it’s the right expert, we want to work with them wherever they are. Our class of small molecules is not one with which many traditional CDMOs are familiar. We can’t pay or wait while we educate CDMOs on how to synthesize molecules. So we’ve looked for companies globally that have specific experience. But,” she adds quickly, “we now do it with backup plans A, B and C.” L

This article originally appeared on OutsourcedPharma. com on November 3, 2017. Marilyn Bruno, CEO, Aequor, was a speaker at Outsourced Pharma San Francisco 2017. LIFESCIENCELEADER.COM

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Do you use dual sourcing to improve security of purchased materials supply?

A THE SIMPLE ANSWER IS “IT DEPENDS.” Our approach considers three main factors: (1) patient impact (i.e., is this a life-saving product, and is there an alternative available?), (2) business impact (i.e., risk to reputation and product revenue), and (3) raw material time-to-replacement. By applying these factors to all our products, we can identify our most critical products and their associated raw materials and develop an appropriate strategy for continuity of supply. For sole-sourced critical materials (only one source exists), our continuity strategy is likely limited to holding additional inventory and/or qualifying another site for the current supplier. For single-sourced critical materials (only one source qualified), protection strategy options include dual-sourcing, alternate site with existing supplier, or inventory. Sub-tier visibility is important in determining single-source risk at the sub-tier level.

How do you do demand versus capacity long-range planning?

A LONG-TERM CAPACITY STRATEGIES involve a range of assumptions and predictions about product demand, technological innovations, and the shifting competitive landscape. The forecasted growth and variability in demand, in combination with the confidence in those predictions, are core parameters. For example, when demand is more uncertain (e.g., during a new product launch), a larger “buffer” should be available. Pay attention not just to how much capacity is needed but also to what type is required and how it will be measured. Workforce capabilities often are more important when determining plant capacity than facility size or equipment output. Timing for adding/reducing capacity, and by how much, also needs to be considered. Is the strategy to stay well ahead of demand and never run short or maximize utilization and bring new capacity on just-in-time? While delaying expansion can clarify the capacity picture, the risk and impact of falling short (compared with having underutilized plants) should be weighed carefully.

ANU HANS

is VP & chief procurement officer, enterprise supply chain for Johnson & Johnson, and is responsible for developing and executing supplier and spend-management strategies.

What are you working on outside of your role as plant manager for MSD Pharmaceutical Operations at Merck? A AS AN ACTIVE MEMBER OF MEXICO’S CANIFARMA (National Chamber of the Pharmaceutical Industry), I’ve been presiding over its Operations & Manufacturing Commission for the last three years. This is a diverse group of pharma executives, representing both national and multinational companies, with an ambitious agenda of positioning our pharma industry as a priority endeavor for the Mexican government. The potential impact could include enhanced incentives and benefits for our industry, emphasis on R&D activities, and a more secure supply chain through the development of world-class, highly compliant local sources of supply. With a highly respected and progressive regulatory environment and a technically skilled workforce, these efforts will continue to provide Mexico with the tools to become a prominent member of the world’s pharma community.

SANDRA POOLE

is a former EVP of technical and commercial operations at ImmunoGen and SVP, biologics manufacturing at Genzyme.

Knowing what you know now, what would you do differently in managing teams?

A I WOULD PUT GREATER EMPHASIS on giving my staff challenging responsibilities. We talk about celebrating failure and letting people learn from their mistakes, but it is difficult to not tighten control as the stakes get higher. Letting people practice on low-risk activities is fine, but everyone needs to be put into a situation where the risk is real, the pressure is high, and the responsibility for outcomes is their own. Interestingly, the tougher the situation, the bigger the learning and, in my experience, the better the performance. Strong employees respond to big challenges. Empowering staff members to lead and control their own projects has brought success with employee development and the projects themselves. However, it is an ongoing struggle to remember to do this, and to do it in such a way that the possibility of failure does not become a guaranteed failure.

RAUL DIAZ

is plant manager for MSD Pharmaceutical Operations at Merck and directs the Merck Manufacturing Division’s (MMD) human health operations in Mexico. For the last 26 years, he has managed MMD

What’s next in processes and facilities?

A ON THE PROCESS SIDE, SINGLE-USE TECHNOLOGIES are rapidly being implemented, especially in bioprocesses. This can be seen in the growth rates of single-use suppliers and new bioprocessing sites that chose to implement single-use process equipment (when the volume range allows it). This process technology functions as an enabler for new facility designs, for example, creating cleanroom islands surrounded by media and buffer supplies within a larger open area. The future for processes and facilities holds a higher degree of standardization as well as platform designs that can be deployed within months. Today’s capacity needs and increased competitive pressure make many legacy systems obsolete, creating the need for more outside-the-box mind-sets.

MAIK JORNITZ

is CEO of G-CON Manufacturing and founder of BioProcess Resources. He has more than 30 years of experience.

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MARK PETRICH, PH.D., PE

is director, Single-Use Systems Engineering at Merck. He serves as second vice chair of the Bio-Process Systems Alliance.

What is the most interesting post-retirement experience you have had, and why?

A AFTER 30+ YEARS OF 50+ HOUR WORKWEEKS, my intention was to retire but do some industry consulting. While I didn’t miss the intensity of a Big Pharma job, I did miss the passion that drives improving healthcare. Coaching a few small firms has helped me to fill that void. Interestingly, as a coach there is little I need do to set companies up for success. I share experiences, ask questions to clarify intentions and approaches, and thereby help others to lead. Though leaders face a choice of how much they do versus how much they allow others to do, coaches do not. In my opinion, the role of a leader should be much more aligned to that of a coach — creating the conditions for success. While this was my approach in industry, retirement provided me the opportunity to relearn this valuable lesson from a new perspective.

JAMES ROBINSON

is the former VP of vaccine and biologics technical operations for Merck

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Insights

OPERATIONS

By R. Wright

Consent Decrees And Other Formative Site-Leadership Experiences

CONSENT DECREES AND OTHER FORMATIVE SITE-LEADERSHIP EXPERIENCES

R O B W R I G H T Chief Editor

@RfwrightLSL

Ever operate under an FDA consent decree? The term itself will strike fear in most biopharmaceutical manufacturing executives. For it is a legal agreement reached between a company and the FDA detailing the voluntary actions pledged by the affected company to remedy nonconformance to current good manufacturing practice (cGMP) requirements, and it is necessary to avoid FDA litigation.

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ery early in his career, while working at a two different companies before joining GSK, Michael Szymanski, had not one, but two consent decree experiences. Szymanski, who is currently the director at GSK’s Marietta, PA, vaccine manufacturing site, recalled the first time he heard about a consent decree. “I remember asking why it was such a big deal.” Today he knows better. In fact, as the leader of a GSK facility responsible for producing about 90 million doses of vaccines annually, Szymanski does everything in his power to avoid such a dilemma. In the summer of 2017, Szymanksi toured me through his facility and then sat down to share some additional insights on how he and his leadership team approach managing the site. (Read the in-depth article regarding this visit on page 16)

WHAT IT’S LIKE WORKING UNDER A CONSENT DECREE “Working under a consent decree results in losing control of your business,” Szymanski explains. “When you enter into such an agreement, typically a third-party certifier such as a consulting firm is brought in to act on behalf of the FDA and is present in all of your dayto-day decisions.” For a manufacturing organization working to produce and release batches on a daily basis, this means that third party not only needs to understand what’s being done, but is in agreement with decisions being made. “That’s what I mean by loss of control,” he continues. “The company and the responsible person at the organization can’t make the decisions they were hired to make.”

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From this experience he learned the importance of identifying the expectations of the third party overseer up-front and then having built-in touchpoints throughout the project to make sure those expectations are being met. Today he understands that such an approach is just good project management. “As a junior director or manager, having those crucial early conversations about meeting a deliverable, and then getting comfortable resolving conflicts during the process, were foundational experiences as I moved into positions of increased responsibility and accountability,” he attests.

PEOPLE, EMOTIONS, AND OTHER LEADERSHIP LESSONS In dealing with a consent decree, Szymanski also learned a lot about people. “It’s not about how someone feels about a situation,” he explains. “It’s about what are the rules and expectations.” When making big decisions, whether related to personnel, batch status, or meeting or missing a target, it’s human nature for emotions to be involved. These have to be acknowledged if one wants to move a team toward understanding the real issue. “I know you’re uncomfortable,” he says as he begins to demonstrate how such a conversation takes place. “But let’s talk about what’s the requirement, why you’re uncomfortable, why you don’t feel we are meeting this expectation or requirement. Then, let’s figure out how to solve the problem.” For Szymanski, understanding how emotions drive people’s opinions and perspectives and learning to acknowledge their presence during crucial conversations in order to move forward were critical lessons learned

during his formative years. “Our educational system (i.e., high school and college) does not, in any way, prepare people for leadership,” he attests. “I learned about leadership through career progression and difficult transitions.” For example, one of Szymanski’s most difficult transitions was becoming a first-line leader. “You’re part of a peer group, but then, because you know how to do a test method, or how to run a piece of equipment, you get promoted to be a supervisor,” he explains. “All of a sudden you are responsible for a group of people that you used to go to happy hour with and complain about the supervisor. Only now — you’re the supervisor.” Success depends on acquiring new skills. “For many years, biopharmaceutical manufacturers promoted people who were technically superior; those who truly understood the manufacturing process,” he shares. While such people are capable of solving chemical, biological, and engineering problems, they may not be the best leader of people. Though this is something Szymanski learned early, he continues to work on it with his Marietta team during management selection and succession planning. “We manufacture injectable products designed to prevent healthy children from getting sick, so we can’t

make mistakes,” he explains. “We need leaders who can engage, motivate, and educate their employees while being comfortable operating in a VUCA environment.”

EVER HEARD OF VUCA? VUCA (i.e., volatility, uncertainty, complexity, and ambiguity) is a term Szymanski picked up more recently at the U.S. Army War College in Carlisle, PA. “I got exposed to VUCA through a relationship with a professional leadership coach as part of my continued leadership development at GSK,” he says. When Szymanski expressed his interest in becoming a site director, his boss at the time felt he needed to have some conversations around what it meant to go from being a technical manufacturing leader to site director. “You’re moving from knowing a lot about a small portion of the business to knowing a lot less about a bigger portion of the business and becoming comfortable in the aloneness of that role,” he continues. “As the site director, my boss is 5,000 miles and six hours away. And as the Marietta facility runs 24/7, people look to me for confidence, direction, and clear decision making. So you have to be prepared to be resilient in order to manage through the volatility of the business.” L

THE OUTSOURCING INDUSTRY HAS NEVER TALKED LIKE THIS BEFORE. Outsourced Pharma Conference & Exhibition is a vibrant forum that builds a community for networking and discussion. OUTSOURCEDPHARMAEVENTS.COM

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Insights

LEADERSHIP LESSONS

By J. Robinson

Plant Management

PLANT MANAGEMENT 101

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JIM ROBINSON

JIM ROBINSON is a retired pharmaceutical executive with more than 30 years of experience in biological process development and manufacturing in US Pharma and Biotech. He currently coaches and consults part time.

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ften as our careers advance, we find that the skills that earned us the opportunity to do new things are not the same skills that are needed at that next level. A key example of that is the move to plant management. Many can master the focus and attention needed when managing a single laboratory. The broader job of managing a site does not generally allow that same focus on every detail and forces the plant manager to rely on the network of people that manage the production, testing, facilities, quality, supply chain, and other aspects of a portfolio of products. When I tried to do everything, I received the following advice from my manager – “As a leader, if you are doing the work, you aren’t doing your job.” The work is what you know, managing the network so this work gets done becomes the job.

PERFORMANCE, PROCESSES, AND PEOPLE — IT’S WHAT MAKES THE OPERATION RUN Understanding the required outputs of your plant, then focusing on delivering those outputs consistently and reliably is paramount. This is your plant performance. It is THE deliverable for you and your team. There are no explanations or excuses that will satisfy the patient or your company if this performance falls short of the patient or business. Other functional leaders may not generally care HOW you do it, provided they get from you what they need. Defining the outputs and the key leading performance indicators (KPIs) that allow you to confirm that the output will be delivered, or that will identify issues in time to resolve issues such that out-

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put is not impacted, is key. These plant output targets and KPIs should be well known by all in your team as well as by your manager. Performance against targets should be tracked and visible throughout the plant. The performance is supported by capable organizational, quality, and manufacturing processes. Processes are agreed methods for how people work together to deliver outcomes. Your main lever as the leader of this organization is to shape and improve the processes that allow work to get done efficiently and effectively, especially when they involve external groups. To use a North American football analogy, I think of myself not as the quarterback, but the offensive linemen – that large force that clears obstacles for others to deliver the results. Organizationally, the leader is better positioned to develop and improve processes and negotiate with other functional groups to best support the teams needs in executing work. Finally, the people make the organization and ultimately deliver the product. I rely on the principles from “The Elements of Great Managing” by Rodd Wagner and Kames Harter. These principles include providing clarity of what is expected of each person to deliver the objectives and strategy; ensuring availability of required materials and equipment; providing opportunities for people; recognition and praise; caring for employees; continual training and development of all employees; listening to employee needs; connecting people to the mission and strategy; and other approaches that drive the culture of high employee engagement, satisfaction, and personal accountability will support the health and productivity of the people to complete the recipe for success. Connecting employees and their work with plant output targets and what the patient needs, is an important element of the overall communication and management strategy. Again, these are the activities executed by the leadership team and cascaded and enrolled by the leader to all levels of the organization. Whereas there are processes to ensure the work gets executed, there are also parallel processes to support the culture of the organization. People need information to do their work and to stay

connected and up to date with the strategy. Clear, concise, and value-added communication that supports work, strategy and the cultural elements noted above should be routine and audience-appropriate. I find most organizations under communicate. Some people will want more information than others. However, you can also over communicate, diluting the most important information and creating confusion or fatigue. Find the right balance (and improving the process over time), including alternatives for people who want more information, while making sure everyone gets the right core information, well-aligned with the objectives and strategy. Remember, in each communication, you are lucky to deliver 2 or 3 key messages. For retention, these key messages should be repeated multiple times (4-6 times for high retention), and preferably in real-life context to help employees connect with the message. What many companies miss in this process is that communication is a TWO WAY exchange of information. Remember to create and encourage effective processes for employees to communicate issues and concerns to management, not just the communication of management information to employees.

WALK THE PLANT I have always liked “Management by Walking Around”. Seeing the operations routinely helps to establish what is “normal” and thereby recognize when something is “different”. Spotting atypical situations allows you to ask better questions and to understand what may be an early indicator of a or developing issue. I have learned, however, that when engaging with employees, I must behave in a way to support the plant leadership team and not short-circuit chain of command. Keeping all levels of management engaged in the communication and the management of the performance, processes, and people is important. The plant manager must be disciplined in their actions to maintain the ecosystem. Your availability to the greater team by walking about the plant is a means to stay connected, recognize significant achievements of an area, to bring focus to issues, to show their work is important to you, to increase morale by showing you are aware and supportive of their contributions, and to reinforce messages that have been cascaded through your leadership team. It is not intended for you to personally and directly address every issue raised, nor is it circumvent your leadership team’s responsibilities. It can be a good means to hear if your messages are clearly cascaded in the proper context, and to get feedback from the organization on issues that are not being escalated through your leadership team. I bring my learnings, good and bad, back to my staff meetings (without exposing specific employees)

for course corrections and for group learning rather than addressing it myself on the tour. A critical action here, however, is to ensure the follow-up happens. Making promises that are not fulfilled (“I’ll look into that”) will quickly reduce the impact of your presence and this process. Keep notes on your tours, issues heard, commitments made, etc., and follow-up on whether the employees have seen progress since prior tours. An added value of you doing MBWA, is that it encourages your leadership team to do the same, so they can spot and address issues in advance and make your tours uneventful. When these processes cascade to multiple levels with the cultural elements of “The Elements of Great Managing”, you should expect to see great achievement of your plant output.

WALK THE TALK Much of what is outlined above relies heavily on effective leadership behaviors from your staff (and theirs). It is critical that the plant manager leads strongly by example in how they lead, develop, motivate, and communicate with their own staff, as well as coaching them to do the same so these good practices cascade through the organization. I use routine face-to-face meetings with each staff member to proactively review what their operations issues are, how they are advancing on their objectives, their professional development plans, and how they are managing their own employees. The face-to-face meetings have a quarterly rotation of topics to ensure key messages are addressed throughout the year and so that issues can be identified and tracked to completion before they impact plant output. I also keep a register of each of these key areas (issues, objectives, development goals, KPIs) up to date for my face-to-face meetings; this register becomes part of my monthly report to my leadership, so they are likewise aware of the issues and how we are addressing them to avoid business impact. This shows your manager that you are focused on the full array of issues that come with the job. Please note, that this register should include “good news” (good performance metric performance, objectives on target) as well as issues to be resolved to keep a realistic and balanced perspective on the plant’s performance.

FINAL THOUGHTS The role of a plant manager was one of the most fulfilling and satisfying experiences in my career. It didn’t start out that way. I hear this is normal. Hopefully, the lessons I have learned and articulated can shorten the path to efficient and effective achievement of a high performing plant, team, and plant manager. Enjoy the ride. L LIFESCIENCELEADER.COM

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