Senior CMC & QA Manager - Radiopharmaceuticals

Regulatory Jobs; Indianapolis (IN); On-site; USD 142,000 - 171,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being & Protection

Paid Time Off

Job summary

RayzeBio, headquartered in Indianapolis, seeks a Senior Manager of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics in development. This role emphasizes change control, method lifecycle oversight, risk assessments, and collaboration with Regulatory for filings and health authority updates, with strong cGMP knowledge.

Based at the Indianapolis facility, you will drive QC improvements, oversee multiple projects, and ensure QA excellence across

Qualifications

• 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.
• Experience in Quality with radiopharmaceuticals or biologics preferred.
• Thorough knowledge of cGMPs and regulatory requirements (FDA, EU, ICH).

Responsibilities

• Provide QA input from pre-clinical to end of product life cycle and develop/approve CMC strategy for DS, DP, and analytics.
• Own change control management and QA oversight of Deviations, Investigations, CAPAs, and Complaints.
• Review analytical method lifecycle documents and ensure stability and qualification of methods.
• Collaborate with Regulatory to track quality input for IND/IMPD/BLA/NDA filings and health authority updates.
• Act as final QA reviewer/approver of QA events and participate in investigations as required.

Skills

CMC expertise

Radiopharmaceuticals/biologics

FDA/ICH regulatory knowledge

QA problem-solving

Analytical mindset

Team collaboration

AI in QA

Strategic thinking

Education

B.S. in Chemistry/Biochemistry

Job description

RayzeBio, headquartered in Indianapolis, seeks a Senior Manager of CMC - Quality Assurance to lead QA strategies for drug substance, API, drug product, and analytics in development. This role emphasizes change control, method lifecycle oversight, risk assessments, and collaboration with Regulatory for filings and health authority updates, with strong cGMP knowledge.

Based at the Indianapolis facility, you will drive QC improvements, oversee multiple projects, and ensure QA excellence across