Senior Manager of CMC - Quality Assurance

Bristol Myers Squibb • Indianapolis, IN

7d • Onsite

About The Position

The Senior Manager of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for compounds in Development (radiopharmaceuticals). The emphasis of the position will be at the Indianapolis manufacturing facility and therefore, the incumbent must be located at the site. The incumbent will be responsible for multiple projects, which may be at the Indianapolis site, San Diego, and/or CMOs.

Requirements

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.
• Five plus years of hands-on biologics/sterile experience within a development/operations facility -manufacturing and/or analytical. (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.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.
• Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.
• Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
• Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
• Excellent investigational and QA problem-solving skills.
• Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.
• Ability to work independently, yet effectively in a team environment.
• Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
• Applies AI to improve team execution and decision‑making
• Other proven competencies such as strategic thinker, influencer and negotiator are required.
• Continuous improvement mindset is also required.

Nice To Haves

• Prior experience in Quality

Responsibilities

• Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle, including NDA filing, other market filings, and post approval changes.
• Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.
• Responsible for change control management, for compound/product-specific changes, through the product lifecycle to include impact assessments, tracking, and implementation.
• Responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate including, Deviations, Investigations, CAPAs, and Complaints.
• Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.
• Work with CMC Teams to conduct compound/product specific 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.
• Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior