Scientific Director/Senior Scientific Director, CMC Team Leader
Scientific Director/Senior Scientific Director, CMC Team Leader
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Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: 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 youll have the opportunity to grow and thrive through vast and diverse opportunities. Youll 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
#GPS2025
If you come across a role that intrigues you but doesnt 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 account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical pharmacy dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability life insurance supplemental health insurance business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption and surrogacy reimbursement fertility/infertility benefits support for traveling mothers and child elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff customers patients and communities. As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
