QC Lab Supervisor

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.

About GeneFab GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.