Manager, Quality Control Bioassay
Insmed Incorporated
June 30, 2026
On-site
San Diego, CA
Operations
About the Role:
Manager, Quality Control - Bioassay (Quality Control). 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 GMP process monitoring, stability, and release (e.g., SDS-PAGE, western blot, ddPCR/qPCR) and primary mammalian cell culture.
- Manage timely execution of routine QC testing, data review, and summary report preparation.
- Supervise day-to-day activities of direct reports.
- Develop timelines, protocols, and reports for assay transfers and qualifications/validations.
- Serve as an SME with CDMOs for method transfer and testing.
- Author/review QC analytical SOPs, protocols, and reports.
- Perform quality management activities (deviation, CAPA, change control, OOS/OOT/anomalous result investigations) within the company QMS.
- Maintain QC lab; track critical reagents/equipment logbooks; ensure calibration.
- Use LIMS to submit samples, enter data, and track samples.
- Use statistical analysis software to generate control charts and recommend acceptance criteria.
- Become proficient in lab instrument software for testing.
- Help establish the lab and participate in hiring QC staff.
Qualifications:
- Bachelor’s degree + 7 years OR MS + minimum 5 years relevant industry experience.
You Are Or You Also Have:
- Pharmaceutical GMP testing experience, ideally across development through commercial drug product testing; GMP QC release testing experience.
- Method optimization experience (cell-based potency, molecular biology, protein chemistry assays).
- Experience with relevant instrumentation/software (e.g., JESS, droplet digital PCR systems, cell counters, PLA).
- Significant FDA-regulated environment experience.
- Strong organizational and communication skills; willingness to take on new challenges.
Nice to Have:
- Experience with JMP statistical software.
Where You’ll Work / Travel:
- San Diego office; full-time, in-person.
- Minimal travel expected.
Manager, Quality Control - Bioassay (Quality Control). 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 GMP process monitoring, stability, and release (e.g., SDS-PAGE, western blot, ddPCR/qPCR) and primary mammalian cell culture.
- Manage timely execution of routine QC testing, data review, and summary report preparation.
- Supervise day-to-day activities of direct reports.
- Develop timelines, protocols, and reports for assay transfers and qualifications/validations.
- Serve as an SME with CDMOs for method transfer and testing.
- Author/review QC analytical SOPs, protocols, and reports.
- Perform quality management activities (deviation, CAPA, change control, OOS/OOT/anomalous result investigations) within the company QMS.
- Maintain QC lab; track critical reagents/equipment logbooks; ensure calibration.
- Use LIMS to submit samples, enter data, and track samples.
- Use statistical analysis software to generate control charts and recommend acceptance criteria.
- Become proficient in lab instrument software for testing.
- Help establish the lab and participate in hiring QC staff.
Qualifications:
- Bachelor’s degree + 7 years OR MS + minimum 5 years relevant industry experience.
You Are Or You Also Have:
- Pharmaceutical GMP testing experience, ideally across development through commercial drug product testing; GMP QC release testing experience.
- Method optimization experience (cell-based potency, molecular biology, protein chemistry assays).
- Experience with relevant instrumentation/software (e.g., JESS, droplet digital PCR systems, cell counters, PLA).
- Significant FDA-regulated environment experience.
- Strong organizational and communication skills; willingness to take on new challenges.
Nice to Have:
- Experience with JMP statistical software.
Where You’ll Work / Travel:
- San Diego office; full-time, in-person.
- Minimal travel expected.