We are seeking a highly motivated, detail-oriented, and collaborative QC Laboratory Supervisor to lead the weekend shift (Wednesday – Saturday) operations within our Quality Control laboratory supporting cell and gene therapy products. The ideal candidate will possess strong technical expertise in analytical testing and laboratory operations, demonstrated leadership experience in a GMP-regulated environment, and a commitment to maintaining the highest standards of quality, compliance, and operational excellence.
This individual will play a key role in ensuring the timely execution of testing activities, supporting clinical and commercial manufacturing programs, and fostering a culture of continuous improvement, teamwork, and customer-focused service.
Responsibilities
- Supervise daily operations of the QC laboratory, including testing, and data review for in-process, release, and stability testing of cell therapy products.
- Support review and approval of:
- Raw Materials data
- In-process testing
- Release testing
- Stability testing
- Method transfer documentation
- Qualification and validation protocols/reports
- Verify laboratory investigations, deviations, and OOS/OOT documentation are scientifically sound and properly documented.
- Support investigation of out-of-specification (OOS), out-of-trend (OOT), and deviation events. Assist with root cause analysis and implementation of CAPAs.
- Review laboratory notebooks, worksheets, electronic records, chromatographic data, calculations, and supporting documentation.
- Support batch disposition activities through timely QC documentation review.
- Coordinate scheduling of resources, lab activities, and shift coverage to meet production timelines.
- Review laboratory data, calculations, and documentation for accuracy and completeness.
- Approve test results and ensure timely data entry into LIMS or equivalent systems.
- Oversee maintenance and calibration of laboratory equipment and manage lab supply inventory.
- Support method qualification, transfers, and validation activities as needed.
- Collaborate cross-functionally with Manufacturing, QA, AD, MSAT, and other departments to support product release and continuous improvement efforts.
- Author and revise QC SOPs, work instructions, protocols, and reports as needed.
Qualifications
- Bachelor’s degree in biology, chemistry, biochemistry, or related scientific discipline; advanced degree is a plus.
- 5 + years of experience in Quality Control in a GMP-regulated environment, with at least 1–2 years in a supervisory or team lead role.
- Hands-on experience with cell therapy-related analytical methods such as flow cytometry, ELISA, qPCR, and cell-based assays.
- Strong understanding of GMP, ICH, USP, and regulatory requirements applicable to biologics/cell therapies.
- Excellent organizational, communication, and leadership skills.
- Proficiency in electronic systems such as LIMS, Empower, and Veeva.
- Comfortable in a fast-paced, dynamic biotech environment with shifting priorities.
- Demonstrated ability to foster a culture of accountability, quality, and continuous improvement.
- May need to support and/or execute analyst tasks on a non-routine basis.
Skills Required
- Bachelor's degree in biology, chemistry, biochemistry, or related scientific discipline
- Advanced degree (MS/PhD) in a scientific discipline
- 5+ years experience in Quality Control in a GMP-regulated environment
- 1-2 years supervisory or team lead experience
- Hands-on experience with flow cytometry, ELISA, qPCR, and cell-based assays
- Strong understanding of GMP, ICH, and USP regulatory requirements for biologics/cell therapies
- Proficiency with electronic systems such as LIMS, Empower, and Veeva
- Excellent organizational, communication, and leadership skills
- Ability to work in a fast-paced, dynamic biotech environment and foster continuous improvement
- Willingness to lead and work the specified weekend shift (Wednesday–Saturday)
- Ability to support and/or execute analyst tasks on a non-routine basis
What We Do
GeneFab is a contract development, manufacturing, and synthetic biology biofoundry focused on cell and gene therapies. The company bridges innovation and manufacturing with end-to-end biotechnology services, combining computational design and data analysis with cGMP-compliant production to advance genetic medicines from concept to clinic, partnering with innovators to deliver life-changing therapies to patients in need.
