QC Manager
Precigen
June 27, 2026
On-site
Germantown, MD
$95,000 - $120,000 USD yearly
Operations
General Description:
- Oversee a team of QC Analysts and maintain the QC Laboratory in a 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/guide deviations/CAPAs from QC Analysts.
- 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 control, and critical reagents.
- Track equipment cleaning, preventive maintenance, and calibration schedules.
- Review equipment IQ/OQ/PQ documentation (IOQs) and re-qualifications.
- Drive QC process/procedure continuous improvements.
Education and Experience:
- BS in Biological Sciences, Bioengineering, or Chemistry.
- 7+ years performing QC activities in pharmaceutical/biotech under GMP guidelines across multiple disciplines/assays.
- 2+ years supervisory experience.
- Advanced QC testing experience in pharmaceutical/biopharmaceutical labs.
- Familiarity with qPCR, HPLC, ELISA, and cell-based assays.
Desired Key Competencies:
- Manage teams and work independently; review data and provide summary analysis.
- Support regulatory/client audits and interact with clients.
- Strong collaboration, negotiation, communication (verbal/written).
- Self-motivated, proactive, accountable, flexible; mentor key employees.
- High attention to detail, strong documentation, scientific/analytical problem-solving.
- Comfortable in fast-paced small company environment with shifting priorities.
Application instructions:
- None provided.
- Oversee a team of QC Analysts and maintain the QC Laboratory in a 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/guide deviations/CAPAs from QC Analysts.
- 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 control, and critical reagents.
- Track equipment cleaning, preventive maintenance, and calibration schedules.
- Review equipment IQ/OQ/PQ documentation (IOQs) and re-qualifications.
- Drive QC process/procedure continuous improvements.
Education and Experience:
- BS in Biological Sciences, Bioengineering, or Chemistry.
- 7+ years performing QC activities in pharmaceutical/biotech under GMP guidelines across multiple disciplines/assays.
- 2+ years supervisory experience.
- Advanced QC testing experience in pharmaceutical/biopharmaceutical labs.
- Familiarity with qPCR, HPLC, ELISA, and cell-based assays.
Desired Key Competencies:
- Manage teams and work independently; review data and provide summary analysis.
- Support regulatory/client audits and interact with clients.
- Strong collaboration, negotiation, communication (verbal/written).
- Self-motivated, proactive, accountable, flexible; mentor key employees.
- High attention to detail, strong documentation, scientific/analytical problem-solving.
- Comfortable in fast-paced small company environment with shifting priorities.
Application instructions:
- None provided.