Scientific Director/Senior Scientific 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. 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 .

Business Unit Summary

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.

Position Summary

The Scientific Director/Senior 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. Supporting the Product Development portfolio, which includes small molecules, large molecules and new modalities (conjugates, peptides and oligonucleotides), this unique role is critical to our role turning molecules into medicines.

This role may be appointed at the Director or Senior Director level. Candidates with demonstrated experience and expertise will be considered for the appropriate level.

Primary Responsibilities (applies to both levels):

• Leads the interdisciplinary matrix teams responsible for developing and executing compound-specific integrated CMC strategies that advance R&D Project Team objectives and encompass drug substance, drug product, analytical, quality, regulatory, and clinical supplies.
• Represents the Global Product Development and Supply (GPS) organization on key R&D Project Teams, actively collaborates across functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) and influences the BMS organization to develop globally optimized program strategies.
• Communicates and partners effectively across functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute the CMC strategy for the project. Identifies and escalates key issues, risks and resource allocation needs, as appropriate
• Accountable for managing multiple assets across large and small molecules, ranging across phases of development from candidate nomination, First-in-Human, and pivotal clinical studies, through to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager.
• Accountable for CMC Project budget and applies financial acumen to evaluate portfolio trends and anticipate the impact of strategic inflection points on project trajectories. Works with a ‘return on investment’ mindset to define project opportunities, seeking to optimize PDs impact within the broader portfolio.
• Influences CMC regulatory strategies and critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, and information requests.
• Champions operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives, including the adoption of advanced digital capabilities, planning tools and program simulation. Partners with the GPS Business Development group to support Due Diligence evaluations and activities to bring assets into the GPS network and partner with alliance management, as necessary.

Qualifications & Experience

Director Level

• Advanced degree in relevant scientific discipline
• 12+ years of relevant CMC experience in the pharmaceutical industry.
• Solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development.
• Exceptional verbal and written communication skills with a proven ability to influence and align stakeholders across all levels and functions within a complex matrix environment, including both internal and external partners.
• Keen sense for value and understanding of investment strategy, ability to apply risk-balanced and differential investment principles to enhance CMC operations and drive organizational success
• Capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation.
• Ability to manage ambiguity and make decisions with limited information, when required.
• Demonstrated ability to operate as an enterprise leader, driving clarity and influence to advance business objectives
• Broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development and/or leading CMC teams throughout the development lifecycle, from early-stage development through commercialization.
• Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus.
• Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose
• Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity

Senior Director Level

• Advanced degree in relevant scientific discipline
• 15+ years of relevant CMC experience in the pharmaceutical industry.
• Robust understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development.
• Capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation.
• Excellent verbal and written communication, as well as strong problem-solving, and decision-making skills.
• Proven track record of influencing and building strong partnerships with diverse stakeholders across the organization to achieve strategic goals.
• Keen sense for value of investment with a proven track record of applying risk-balanced and differential investment principles to enhance CMC operations and drive organizational success.
• Demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture.
• Ability to manage ambiguity and make decisions with limited information, when required
• Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus.
• Broad and deep understanding of chemical and/or biological, formulation and analytical development and a proven track record of leading CMC teams throughout the development lifecycle, from early-stage development through commercialization
• Experience working with external manufacturing organizations (CMOs) and managing complex supply chains and budget.
• Demonstrated success in developing and/or applying innovative solutions to complex CMC technical challenges.
• Strong knowledge of global regulatory guidelines and requirements (e.g., FDA, EMA, ICH guidelines).
• Embraces BMS shared values of passion, innovation, urgency, accountability, inclusion, and integrity

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into