QC Lab Supervisor

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. $130,000 - $150,000 a year We welcome qualified candidates and are an equal opportunity employer. #J-18808-Ljbffr GeneFab