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 contents 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.