Manager, Quality Control
Precigen
August 20, 2026
On-site
Germantown, MD
$105,000 - $140,000 USD yearly
Operations
General Description:
- Oversee a team of QC Analysts and maintain the QC Laboratory in state of cGMP compliance.
Duties and Responsibilities:
- Train, coach, and develop QC staff.
- Develop, revise, and review SOPs, qualification/validation protocols, and reports.
- Write deviations, CAPAs, and own change controls; review/provide guidance on QC-generated deviations/CAPAs.
- Review invalid assays and lead invalid assay investigations; participate in OOS investigations.
- Ensure analytical data is initiated on time and completed within established TATs.
- Review QC documentation (equipment logbooks, solution prep records, cell line records, TRFs, etc.); ensure test results are entered into appropriate reports.
- Track/trend reference standards, assay controls, and critical reagents.
- Track equipment cleaning/PM/calibration schedules; review equipment IOQs and re-qualifications.
- Drive QC process/procedure continuous improvements; perform other duties as needed.
Education and Experience:
- BS in Biological Sciences, Bioengineering, or Chemistry.
- 7+ years QC experience in pharmaceutical/biotech under GMP; expertise in multiple disciplines/assays.
- 2+ years supervisory experience.
- Advanced QC testing experience in pharmaceutical/biopharmaceutical labs.
- Familiarity with qPCR, HPLC, ELISA, cell-based assays (etc.).
Desired Key Competencies:
- Manage a team; work independently; analyze data and provide summary reports.
- Support regulatory/client audits and interact with clients.
- Negotiate and build collaboration.
- Self-motivated, proactive, accountable, flexible; develop/coach/mentor employees.
- Strong communication, attention to detail, documentation, scientific/analytical/problem-solving skills, and sound judgment.
- Comfortable in a fast-paced small company environment with changing priorities.
- Oversee a team of QC Analysts and maintain the QC Laboratory in state of cGMP compliance.
Duties and Responsibilities:
- Train, coach, and develop QC staff.
- Develop, revise, and review SOPs, qualification/validation protocols, and reports.
- Write deviations, CAPAs, and own change controls; review/provide guidance on QC-generated deviations/CAPAs.
- Review invalid assays and lead invalid assay investigations; participate in OOS investigations.
- Ensure analytical data is initiated on time and completed within established TATs.
- Review QC documentation (equipment logbooks, solution prep records, cell line records, TRFs, etc.); ensure test results are entered into appropriate reports.
- Track/trend reference standards, assay controls, and critical reagents.
- Track equipment cleaning/PM/calibration schedules; review equipment IOQs and re-qualifications.
- Drive QC process/procedure continuous improvements; perform other duties as needed.
Education and Experience:
- BS in Biological Sciences, Bioengineering, or Chemistry.
- 7+ years QC experience in pharmaceutical/biotech under GMP; expertise in multiple disciplines/assays.
- 2+ years supervisory experience.
- Advanced QC testing experience in pharmaceutical/biopharmaceutical labs.
- Familiarity with qPCR, HPLC, ELISA, cell-based assays (etc.).
Desired Key Competencies:
- Manage a team; work independently; analyze data and provide summary reports.
- Support regulatory/client audits and interact with clients.
- Negotiate and build collaboration.
- Self-motivated, proactive, accountable, flexible; develop/coach/mentor employees.
- Strong communication, attention to detail, documentation, scientific/analytical/problem-solving skills, and sound judgment.
- Comfortable in a fast-paced small company environment with changing priorities.