CMC QA Lead – Radiopharmaceuticals & Compliance

Regulatory Jobs; Indianapolis (IN); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Employee stock options

Job summary

RayzeBio is seeking an Associate Director of CMC - Quality Assurance at our Indianapolis, IN facility. You will drive QA strategy across drug substance, API, and analytics for radiopharmaceutical programs, partnering with Regulatory and cross-functional teams.

The ideal candidate has 10+ years in biologics/sterile development with cGMP experience and a track record of IND/BLA success. This role requires onsite work at the Indianapolis site and collaboration with San Diego/CMOs as needed.

Qualifications

• Thorough knowledge of pharmaceutical development processes with IND/BLA experience.
• Expertise in radiopharmaceuticals or biologics development and manufacturing.
• Familiarity with cGMPs and regulatory requirements (FDA, EU, ICH).

Responsibilities

• Lead QA input across CMC development from pre-clinical to post-approval.
• Oversee change control, deviations, investigations, CAPAs and QA reviews.
• Collaborate with Regulatory on filings and health authority communications.
• Provide risk assessments and quality guidance throughout development.

Skills

CMC development

QA expert

cGMP knowledge

Regulatory filings

Biologics/radiopharma

Cross-functional leadership

Education

Bachelor of Science in Chemistry/Biochemistry

10+ years biologics/sterile experience

Regulatory familiarity

Job description

RayzeBio is seeking an Associate Director of CMC - Quality Assurance at our Indianapolis, IN facility. You will drive QA strategy across drug substance, API, and analytics for radiopharmaceutical programs, partnering with Regulatory and cross-functional teams.

The ideal candidate has 10+ years in biologics/sterile development with cGMP experience and a track record of IND/BLA success. This role requires onsite work at the Indianapolis site and collaboration with San Diego/CMOs as needed.