Director, CMC Team Leader

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Our Portfolio Strategy and Integration team is dedicated to developing and executing CMC strategies for small molecule and biologics portfolio utilizing the brightest minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and life cycle management, we provide valuable project information and portfolio insights, and we lead CMC due diligence for business development opportunities. Joining PSI means you'll have the opportunity to grow and thrive through vast and diverse opportunities. You'll make a positive impact on the lives of patients while advancing professionally alongside some of the brightest minds in biopharma.

The Director, CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs.

Primary responsibilities of the Director, CMC Team Leader:

• Provides leadership to interdisciplinary, matrix teams responsible for developing and executing compound-specific integrated CMC strategies that drive R&D Project Team objectives and incorporate all elements across the drug substance, drug product, analytical, quality, regulatory, and clinical material spaces.
• Accountable for managing multiple assets, large molecule and/or small molecule, ranging from candidate nomination, First-in-Human, and pivotal clinical studies, to intended commercial formulation and manufacturing processes with appropriate control strategies.
• Represents the Product Development organization on R&D Project Teams and actively collaborates with other functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) to achieve the best development and business results for the company.
• Communicates and partners effectively with functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute CMC strategy for the project. Identifies and escalates key issues and risks as well as resource allocation needs, as appropriate
• Critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
• Promotes best practices and leads improvement opportunities.
• Partners with the GPS Business development group to support Due Diligence evaluations and activities to bring assets into the GPS network, will partner with alliance management, as necessary.

Skills/Knowledge Required:

• Advanced degree in relevant scientific discipline
• 12+ years of relevant CMC experience in the pharmaceutical industry.
• Broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development of clinical stage programs
• Experience in multiple modalities is a clear plus.
• Solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development.
• Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose
• Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
• Keen sense for value of investment, ability to manage ambiguity and make decisions with limited information, when required
• Embraces BMS shared values of passion, innovation, urgency, acco