Senior Manager, CMC Quality Assurance

Working with Us
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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.

BASIC QUALIFICATIONS:

• 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)

#LI-Hybrid

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.

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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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