Job Title: QC Bioanalytical Scientist

Job Summary:

We are seeking a highly motivated and detail-oriented QC Bioanalytical Scientist to perform laboratory method validation, qualification, and transfer activities. The ideal candidate will have experience in cell-based assays, flow cytometry, and drug substance PCR identification. The QC Bioanalytical Scientist will work independently and collaborate with senior team members to ensure successful method qualification, assay transfer, and routine bioanalytical testing.

Key Responsibilities:

• Perform method qualification and participate in bioanalytical assay transfer to ensure the successful start-up of the QC laboratory.
• Conduct compendia method qualifications related to cell-based test assays and flow cytometry. Perform routine analysis of cell culture media, reagents, and cultured cells in-process.
• Utilize analytical methods such as flow cytometry, qPCR, ELISA, and cell viability assays for bioanalytical testing.
• Generate data entry and result reports in the LIMS system, ensuring accuracy and timeliness.
• Monitor instruments for preventative maintenance and ensure conformance to specifications.
• Conduct thorough investigations for any lab event/OOS/OOT/OOE results in the Trackwise system. Ensure IQ/OQ/PQ of newly purchased instruments are completed by the vendor in a timely manner.
• Generate and revise general procedures, protocols, and technical reports as needed.
• Author test methods and specifications, ensuring accuracy and compliance with SOPs.
• Initiate and complete QA-Track records as required.
• Oversee laboratory equipment to maintain optimal temperature and humidity levels, ensuring consistent gas supplies for cell culture facilities.

Required Education/Qualifications/Skills:

• Bachelor’s or master’s degree in biology, Cell Biology, Immunology, Health Sciences, or a related field from an accredited institution.
• Minimum of 2 years of working knowledge in GMP, QC Analytical, or biotechnology/pharmaceutical industry.
• Familiarity with Standard Operating Procedures (SOPs), cell biology, flow cytometry, analytical test methods, and generally accepted laboratory practices.
• Comfortable working in a cell culture lab area and with viral-based gene-therapy drugs.
• Experience with LIMS and Trackwise is a plus.