Senior Manager, CMC Quality Assurance
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Manager of CMC QA (Quality) develops Quality strategies for the CMC activities (drug substance, API, drug product, and analytics) for compounds in Product Development (small molecules and biologics). The emphasis of the position will be on biologics compounds but may expand to small molecules and will be responsible for multiple projects.
Responsibilities will include:
Responsible for being the CMC Biologics expert with an ability to introduce best practices into the quality management systems.
Member of CMC Development Teams providing Quality (QA) input from pre-clinical to late-phase development (until start of PPQ – Process Performance Qualification) to BLA/NDA filing.
Partners with technical SMEs (subject matter experts) to develop and approve the CMC strategy for new drug candidates.
Responsible for change control management through the product lifecycle to include impact assessments, tracking, and implementation. Also, as appropriate, responsible Quality member for oversight of all key Quality System deliverables associated with the drug development candidate including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints.
Work with CMC Teams to conduct risk assessments, as required, for all aspects of the drug development process. Responsible for communicating Quality risks within the Quality organization.
Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g., IND/IMPD/BLA/NDA) including specifications, shelf-life extensions, country specific trial approvals, etc.
Bachelor’s degree preferably in Chemistry, Biochemistry, or a similar Scientific field
8+ years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical)
5+ years of Quality experience in life sciences industry
An equivalent combination of education and experience may be substituted
Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval
Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.) and parenteral (cold chain liquid/lyophilized form) drug product is required
Knowledge of devices for biologics (e.g., combination product) would be considered an advantage
Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH)
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
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