Manager, Quality Control Bioassay
Insmed Incorporated
August 13, 2026
On-site
San Diego, CA
Operations
About The Role
Manager, Quality Control - Bioassay (Quality Control team). Reporting to the Associate Director, Quality Control, you will transfer, qualify, and optimize methods across the method lifecycle, and author/implement QC area procedures for an AAV-based gene therapy laboratory.
What You’ll Do
- Oversee cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring, stability, and release in a GMP environment (e.g., SDS-PAGE, western blot, ddPCR/qPCR; primary mammalian cell culture)
- Execute routine QC testing, review data, and prepare summary reports
- Supervise day-to-day activities of direct reports
- Develop timelines, protocols, and reports for assay transfers and qualifications/validations
- Serve as a subject matter expert for CDMO method transfers and testing
- Author/review QC analytical SOPs, protocols, and reports
- May act as analytical lab representative on a CMC team
- Perform QMS quality management (deviations, CAPA, change control, OOS/OOT/investigations)
- Maintain QC laboratory; track reagents/equipment logbooks; ensure calibration
- Use LIMS to submit samples, enter data, and track samples
- Use statistical software to generate control charts and recommend acceptance criteria
- Become proficient in laboratory instrument software
- Establish laboratory and participate in hiring QC staff
Who You Are
- Bachelor’s degree with 7 years experience, or MS with at least 5 years relevant industry experience
Requirements/Skills
- GMP testing focus, including analytical method/testing lifecycle; experience in GMP QC release testing
- Experience optimizing methods (cell-based potency, molecular biology, protein chemistry assays)
- Instrumentation/software experience for potency assays (e.g., JESS, droplet digital PCR, cell counters, PLA)
- Significant FDA-regulated environment experience
- Entrepreneurial mindset; strong organizational and communication skills
Nice to Have
- Experience with JMP statistical software
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from posting date or until position is filled.
Manager, Quality Control - Bioassay (Quality Control team). Reporting to the Associate Director, Quality Control, you will transfer, qualify, and optimize methods across the method lifecycle, and author/implement QC area procedures for an AAV-based gene therapy laboratory.
What You’ll Do
- Oversee cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring, stability, and release in a GMP environment (e.g., SDS-PAGE, western blot, ddPCR/qPCR; primary mammalian cell culture)
- Execute routine QC testing, review data, and prepare summary reports
- Supervise day-to-day activities of direct reports
- Develop timelines, protocols, and reports for assay transfers and qualifications/validations
- Serve as a subject matter expert for CDMO method transfers and testing
- Author/review QC analytical SOPs, protocols, and reports
- May act as analytical lab representative on a CMC team
- Perform QMS quality management (deviations, CAPA, change control, OOS/OOT/investigations)
- Maintain QC laboratory; track reagents/equipment logbooks; ensure calibration
- Use LIMS to submit samples, enter data, and track samples
- Use statistical software to generate control charts and recommend acceptance criteria
- Become proficient in laboratory instrument software
- Establish laboratory and participate in hiring QC staff
Who You Are
- Bachelor’s degree with 7 years experience, or MS with at least 5 years relevant industry experience
Requirements/Skills
- GMP testing focus, including analytical method/testing lifecycle; experience in GMP QC release testing
- Experience optimizing methods (cell-based potency, molecular biology, protein chemistry assays)
- Instrumentation/software experience for potency assays (e.g., JESS, droplet digital PCR, cell counters, PLA)
- Significant FDA-regulated environment experience
- Entrepreneurial mindset; strong organizational and communication skills
Nice to Have
- Experience with JMP statistical software
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
- Applications accepted for 5 calendar days from posting date or until position is filled.