Manager, Quality Control

Precigen; Germantown (MD); On-site; USD 110,000 - 150,000; Full time

Job summary

Precigen is seeking a Manager, Quality Control to lead a QC team in a state-of-the-art Analytical QC lab in Germantown, MD. You will ensure cGMP compliance, develop SOPs, and drive investigations for deviations and CAPAs.

The role requires guiding staff, coordinating assay work (qPCR, HPLC, ELISA, cell-based assays), and maintaining strict data integrity. Responsibilities include coaching staff, reviewing documentation, supporting audits, and implementing continuous improvements to QC processes

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 pharmaceutical/biopharmaceutical labs.
• Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, cell-based assays.

Responsibilities

• Oversee QC Analysts and maintain cGMP compliance in the QC lab.
• Train, coach, and develop QC staff; review SOPs and validation protocols.
• Write deviations, CAPAs, and own change controls.
• Review deviations/CAPAs and lead investigations; ensure timely data generation.
• Monitor QC data, trend reference standards, and schedule equipment PM/calibration.
• Support regulatory and client audits; interact with clients as needed.
• Continuously improve QC processes and documentation.

Skills

Team leadership

Quality control

Regulatory audits support

Analytical reasoning

qPCR

HPLC

ELISA

Cell-based assays

Education

BS degree in Biological Sciences / Bioengineering / Chemistry

Job description

Job Title: Manager, Quality Control

Department: Quality Control - Analytical

GENERAL DESCRIPTION

• QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.

DUTIES AND RESPONSIBILITIES

• Training, coaching, and development of QC staff
• Develop, revise, and review SOPs, qualification/validation protocols and reports.
• Write deviations, CAPA’s and own change controls.
• Review/Provide guidance for deviations/CAPA’s generated by QC Analysts
• Responsible for reviewing invalid assays and lead invalid assay investigations
• Participating in OOS investigations
• Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT’s.
• Perform review of QC documentation (equipment logbooks, sol’n prep record, cell line records, TRF’s, etc)
• Ensure test results are entered into the appropriate reports
• Track/Trend Ref. Std, Assay Control and Critical Reagents
• Track equipment cleaning/PM/Calibration schedules
• Review equipment IOQ’s and Re-Qualifications
• QC Process/Procedure continuous improvements
• Perform other duties as needed

EDUCATION AND EXPERIENCE

• BS degree in the Biological Sciences, Bioengineering, or Chemistry.
• 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays.
• 2+ years of supervisory experience.
• Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories
• Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.

DESIRED KEY COMPETENCIES

• Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data
• Ability to provide support for regulatory and client audits, as well as interact with clients.
• Ability to effectively negotiate and build collaboration amongst individuals.
• Ability to be self-motivated, proactive, accountable, and flexible
• Demonstrate the ability to develop, coach and mentor key employees.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• High attention to detail, highly organized, and excellent documentation skills
• Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.

EOE/MFDV