Senior Manager, Quality Control
Invivyd
5 hours ago
Remote friendly (New Haven, CT)
United States
$144,000 - $192,000 USD yearly
Operations
Responsibilities:
- Lead and coordinate external testing activities for drug substance (DS) and drug product (DP) release and stability programs, including review and approval of protocols, reports, and raw data packages.
- Serve as QC analytical subject matter expert (SME) for analytical method qualification, validation, transfer, and maintenance for DS/DP methods.
- Perform data trending and statistical analysis of DS/DP release and stability results; lead root-cause evaluation of out-of-trend (OOT) and out-of-specification (OOS) events and ensure effective CAPA/CAPA-like actions.
- Collaborate cross-functionally to establish, justify, and maintain phase-appropriate DS/DP specifications aligned with regulatory expectations.
- Manage and support QC-related quality events (change controls, deviations, OOS/OOT investigations, CAPAs, and other exceptions) with thorough documentation and timely resolution.
- Author, revise, and approve QC procedures and documentation supporting compliant QC operations.
- Provide QC technical expertise for regulatory filings (INDs, BLAs, and other submissions), including responses to regulatory queries and inspection requests.
Requirements:
- Bachelor’s or Master’s degree in a scientific discipline.
- 10+ years of biopharmaceutical industry experience.
- Minimum 5 years in a Quality-focused role supporting QC operations.
- Demonstrated experience managing DS/DP release testing.
- Proficiency with MS Office and statistical/analytics platforms (e.g., JMP).
- Strong experience managing external testing laboratories (highly preferred).
- Experience with infectious disease programs and large-molecule development (highly preferred).
- Experience qualifying, validating, or executing analytical methods in a QC laboratory (highly preferred).
Benefits:
- Base salary range: $144,000–$192,000; eligible for annual short-term incentive and annual long-term incentive (bonus and equity).
Application instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.
- Lead and coordinate external testing activities for drug substance (DS) and drug product (DP) release and stability programs, including review and approval of protocols, reports, and raw data packages.
- Serve as QC analytical subject matter expert (SME) for analytical method qualification, validation, transfer, and maintenance for DS/DP methods.
- Perform data trending and statistical analysis of DS/DP release and stability results; lead root-cause evaluation of out-of-trend (OOT) and out-of-specification (OOS) events and ensure effective CAPA/CAPA-like actions.
- Collaborate cross-functionally to establish, justify, and maintain phase-appropriate DS/DP specifications aligned with regulatory expectations.
- Manage and support QC-related quality events (change controls, deviations, OOS/OOT investigations, CAPAs, and other exceptions) with thorough documentation and timely resolution.
- Author, revise, and approve QC procedures and documentation supporting compliant QC operations.
- Provide QC technical expertise for regulatory filings (INDs, BLAs, and other submissions), including responses to regulatory queries and inspection requests.
Requirements:
- Bachelor’s or Master’s degree in a scientific discipline.
- 10+ years of biopharmaceutical industry experience.
- Minimum 5 years in a Quality-focused role supporting QC operations.
- Demonstrated experience managing DS/DP release testing.
- Proficiency with MS Office and statistical/analytics platforms (e.g., JMP).
- Strong experience managing external testing laboratories (highly preferred).
- Experience with infectious disease programs and large-molecule development (highly preferred).
- Experience qualifying, validating, or executing analytical methods in a QC laboratory (highly preferred).
Benefits:
- Base salary range: $144,000–$192,000; eligible for annual short-term incentive and annual long-term incentive (bonus and equity).
Application instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.