Job Title: Senior Scientist, Drug Product Champion
Location: New Brunswick, NJ (Hybrid)
Department: Biologics Development / Drug Product Development
Reports To: Melissa Bentley
Position Summary:
The Senior Scientist, Drug Product Champion provides technical leadership for new and existing sterile drug products, ensuring robust manufacturing and lifecycle management across one or more sites. The role is responsible for managing the Drug Product (DP) Book of Work, leading matrix teams, supporting technology transfers (TT), investigations, and process improvements, and ensuring compliance with regulatory expectations.
This position requires expertise in Biologics, Aseptic Processing, and Sterile Drug Product Manufacturing. The Drug Product Champion is a key interface between Manufacturing, Analytical, Regulatory, and Quality functions, ensuring that DP processes remain efficient, robust, and aligned with business objectives.
Key Responsibilities:
1. Technical Leadership & Lifecycle Management
Lead Aseptic Drug Product matrix teams for assigned sterile products, acting as the primary technical representative at Technical Product Teams (TPTs).
Manage the Drug Product Book of Work (BOW) and risk register for assigned products.
Serve as a technical expert to support manufacturing sites in resolving complex quality events and deviations.
Provide technical input for change controls and oversee Global Change Control Impact Assessments.
Develop and maintain lifecycle documents, such as Time Out of Refrigeration (TOR) studies and Process Descriptions.
2. Regulatory & Compliance Support:
Review and co-author sections of CMC filings and responses to Information Requests (IRs).
Contribute to End-to-End Robustness Assessments and Annual Product Quality Reviews (APQRs), ensuring a data-driven approach to continuous process improvement.
Maintain oversight of local and global change controls, ensuring proper alignment with quality and regulatory requirements.
3. Technology Transfer & Manufacturing Support:
Collaborate on Technology Transfer (TT) projects, providing technical input, document review, and approval for key deliverables.
Support chartered projects, ensuring seamless drug product transitions across manufacturing sites.
Engage with a core team of specialized experts to support the BMS portfolio of biologics and complement site capabilities.
Qualifications & Experience:
Required:
Strong knowledge in Biologics, Sterile Liquid Drug Products, and Aseptic Processing.
Experience in Biologics/Vaccine Aseptic Drug Product Manufacturing and/or Technology Transfer.
Ability to serve as a technical expert for drug product manufacturing sites.
Strong critical thinking, technical writing, and communication skills.
Proven ability to work in a matrix environment and effectively support decentralized manufacturing functions.
Experience in aligning with cross-functional business partners (Analytical, Regulatory, Quality, and Manufacturing).
Desired:
Expertise in Lyophilization technology with the ability to serve as a technical SME.
Thorough knowledge of Quality Systems, Quality by Design (QbD), and process validation principles.
Understanding of engineering design and process control fundamentals.
Education & Experience:
Bachelor’s degree in a relevant scientific discipline with 5–9 years of experience in drug product development or manufacturing.
Master’s or Ph.D. preferred but not required (advanced degrees may be considered equivalent experience).
Travel & Work Environment:
This role requires up to 30% travel, including visits to BMS manufacturing sites and external partners.
Hybrid work model based in New Brunswick, NJ.
Why Join Bristol Myers Squibb?
At BMS, we are committed to transforming patients’ lives through science. This role offers a unique opportunity to drive technical excellence in drug product development, collaborate with high-performing teams, and contribute to life-saving medicines.
Apply today to be part of an innovative team leading the future of biologics and sterile drug product development!
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