QC Lab Manager — cGMP Oversight & Analytical Team Lead

Precigen; Germantown (MD); Hybrid; USD 105,000 - 140,000; Full time

Job summary

Precigen in Germantown, MD is seeking a Manager, Quality Control to lead a QC team and maintain a cGMP-compliant laboratory. You will oversee training, SOPs, CAPAs, data review, and regulatory-ready documentation.

The role requires 7+ years in QC within pharma/biotech and at least 2 years in supervision, with hands-on experience in qPCR, HPLC, ELISA, and cell-based assays. Strong leadership and cross-functional collaboration are essential.

Qualifications

• BS degree in Biological Sciences, Bioengineering, or Chemistry.
• 7+ years of QC experience in pharma/biotech under GMP.
• 2+ years of supervisory experience.
• Advanced QC testing experience in pharma/biotech labs.
• Familiarity with analytical tests: qPCR, HPLC, ELISA, cell-based assays.

Responsibilities

• Train, coach, and develop QC staff.
• Develop, revise SOPs, qualification/validation protocols and reports.
• Write deviations, CAPAs and own change controls.
• Review deviations/CAPAs from QC Analysts and provide guidance.
• Lead investigations for OOS events and invalid assays.
• Ensure timely entry of analytical data into reports.
• Review IOQs and re-qualifications of equipment.
• Perform other duties as needed.

Skills

Team management

QC oversight

Documentation

Analytical skills

Regulatory audits

Communication

Training coaching

Education

BS in Biological Sciences, Bioengineering or Chemistry

Tools

qPCR

HPLC

ELISA

Job description

Precigen in Germantown, MD is seeking a Manager, Quality Control to lead a QC team and maintain a cGMP-compliant laboratory. You will oversee training, SOPs, CAPAs, data review, and regulatory-ready documentation.

The role requires 7+ years in QC within pharma/biotech and at least 2 years in supervision, with hands-on experience in qPCR, HPLC, ELISA, and cell-based assays. Strong leadership and cross-functional collaboration are essential.