CMC & QA Lead for Radiopharma Development

Bristol-Myers Squibb Co; Indianapolis (IN); On-site; USD 142,000 - 171,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being and Protection

Paid Time Off

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Senior Manager of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics at the Indianapolis facility. You will partner with CMC teams, regulators, and SMEs to drive lifecycle quality, risk assessments, and compliance for radiopharmaceutical programs. Strong molecular development and cGMP experience are required.

Qualifications

• Minimum of a B.S. degree in Chemistry, Biochemistry or a related scientific field.
• Five+ years of hands-on biologics/sterile experience in development/operations (manufacturing or analytical).

Responsibilities

• Provide QA input from pre-clinical to end of product life cycle within CMC Development.
• Lead change control for compound/product changes across lifecycle, including deviations, investigations, CAPAs, and complaints.
• Review and approve API and DP analytical methods, specifications, and protocols/reports including stability.
• Collaborate with CMC teams on risk assessments and communicate QA risks across the organization.
• Coordinate with Regulatory for updates to health authorities and ongoing filings.

Skills

CMC quality leadership

QA strategy

cGMP/regulatory

Problem-solving

Cross-functional collaboration

Independence

Education

B.S. in Chemistry/Biochemistry or related

Tools

Analytical methods

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Senior Manager of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics at the Indianapolis facility. You will partner with CMC teams, regulators, and SMEs to drive lifecycle quality, risk assessments, and compliance for radiopharmaceutical programs. Strong molecular development and cGMP experience are required.