Senior Manager of CMC - Quality Assurance

Job 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.

• Partner with technical SMEs to develop and approve the CMC strategy (drug substance, drug product, and analytical).
• Manage change control for compound/product‑specific changes throughout the product lifecycle, including impact assessments, tracking, and implementation.
• Serve as the quality member and QA approver of all key Quality System deliverables for the candidate: deviations, investigations, CAPAs, and complaints.
• Review and approve compound/product specific analytical method life‑cycle documents (specifications, analytical test methods, protocols/reports) and stability.
• Conduct compound/product specific risk assessments with CMC Teams.
• Communicate quality risks within the quality organization.
• Collaborate with regulatory to track/own quality input for ongoing filings and updates to health authorities (IND/IMPD/BLA/NDA).
• Act as final quality reviewer/approver of quality events and GMP documentation; contribute to investigations as required.

Minimum of a B.S. degree in Chemistry, Biochemistry, or a similar scientific field.

Five plus years of biologics/sterile experience within a development/operations facility (manufacturing and/or analytical). Equivalent combinations of education and experience may be substituted.

Prior experience in Quality and extensive knowledge of the pharmaceutical development processes, including bringing multiple INDs to successful BLA/NDA approval.

Experience with bulk biologic drug substance, parenteral drug product, cell/gene therapy, or radiopharmaceutical development/manufacturing.

Recognized CMC expertise in radiopharmaceuticals and/or biologics, with the ability to introduce best practices into the quality management system.

Thorough understanding of cGMPs and regulatory requirements (FDA, EU, ICH).

Excellent investigational and QA problem‑solving skills, analytical mindset, and ability to work independently and in a team.

Strategic thinking, influencing, negotiating, and continuous improvement mindset.

Regularly required to sit, reach with hands and arms, and talk or hear. Occasionally required to lift or move up to 30 pounds. Must work in a GMP cleanroom environment wearing protective clothing and handling radioactive materials.

Moderate noise level. Work‑related travel outside Indianapolis may be required up to 20% of working time.

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