GeneFab
QC Lab Supervisor
Alameda, CA
Sponsorship not specified$130k-$150kDetected 27 days ago
GMPqPCRCRISPRFlow CytometryProtein AnalysisLeadershipCommunication
About the role
- About GeneFab GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies.
- We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
Responsibilities
- Support review and approval of:
- Support investigation of out-of-specification (OOS), out-of-trend (OOT), and deviation events. Assist with root cause analysis and implementation of CAPAs.
- Support batch disposition activities through timely QC documentation review.
- 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.
- Support investigation of out-of-specification (OOS), out-of-trend (OOT), and deviation events.
Requirements
- 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.
- Proficiency in electronic systems such as LIMS, Empower, and Veeva.
- Demonstrated ability to foster a culture of accountability, quality, and continuous improvement.
- Bachelor's degree in biology, chemistry, biochemistry, or related scientific discipline; advanced degree is a plus.
- Excellent organizational, communication, and leadership skills.
- Comfortable in a fast-paced, dynamic biotech environment with shifting priorities.
- 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.
Nice to have
- Bachelor's degree in biology, chemistry, biochemistry, or related scientific discipline
- advanced degree is a plus.
Compensation
- $130k-$150k
Benefits
- shift coverage to meet production timelines.
Company info
- 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.
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This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.