Quality Control Laboratory Specialist

Quality Control Analytical Team Member

Seeking an energetic and experienced individual with a cell therapy quality control background to join our Quality Control Analytical (QCA) team. The successful candidate will contribute to the advancement of our product pipeline by performing in-process testing, lot release testing, sample management, equipment maintenance, and other assigned tasks. This position is essential for ensuring that the laboratory meets the high standards required for cGMP QCA.

Essential Responsibilities:

• Perform cGMP release testing (e.g. cell counting, flow cytometry, ELISA, cell-based cytotoxicity, dPCR) for cell therapy products and in-process samples.
• Perform in-process flow cytometry testing to support manufacturing operations.
• Support the vialing and cryopreservation of in-process characterization samples.
• Receive, verify, label, store, and track samples, controls, and reagents to ensure traceability and timely transfer to testing laboratories, using paper and electronic systems and operating temperature-controlled units.
• Support laboratory cleaning and equipment maintenance activities.
• Support cell line thawing, passaging and maintenance.
• Author and/or review analytical test results and technical documents, including analytical method qualification protocols and reports, and standard operating procedures (SOPs).
• Document activities, record observations, and complete all paperwork in accordance with cGMPs, SOPs, and protocols.
• Execute protocol-driven method qualification, verification, and validation, and support analytical technology transfer and method lifecycle management activities.
• Escalate and document invalid, OOS/OOT results; support deviations, CAPAs, and change controls; and contribute to investigations as needed.
• Follow Safety, Health, and Environmental procedures, maintain a safe and organized laboratory environment, and use appropriate PPE and aseptic/biocontainment practices.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant cGMP laboratory experience; or Associate's degree preferably in Biology or equivalent with 2-3 years of relevant cGMP laboratory experience.
• The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
• Experience with sample receipt, storage and transfer.
• 1-2 years executing routine and non-routine analysis for cGMP lot release and stability testing using techniques including, but not limited to, cell culture, flow cytometry and cell-based methods, PCR (dPCR, qPCR), immunoassays (ELISA), etc.
• Familiar with basic computer applications such as Microsoft Outlook, Word and Excel.
• Experience operating and maintaining Temperature-Controlled Storage Units.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.

Preferred Qualifications:

• Experience in Cell or Gene Therapy.
• Well versed in various analytical techniques such as flow cytometry, qPCR, dPCR, cell-based potency and/or ELISA experience.