QC Bioassay Analyst (Gene Therapy/Flow Cytometry) - Raleigh Biotech
Our client, a clinical phase biotechnology company in the gene therapy space, is actively recruiting for a very sharp candidate for its Quality Control Bioassay Analyst role. The company is in the process of building out its primary production facility in North Raleigh and this Bioassay Analyst will participate in all daily bioassay activities.
Company will pay generously to attract and retain the right candidate.
Key things to note:
- This company is developing immunotherapies based on its patented gene editing technology. It has numerous products in development – from discovery phase to early clinical.
- This Analyst will complete QC Bioassay activities including flow cytometry, cell counting, ELISA and Polymerase Chain Reaction (PCR) testing. Experience in noted techniques and FACS analysis is required.
- This Analyst will also be responsible for method validation protocols, raw data analysis and troubleshooting unexpected occurrences. Seek a quick study who is an astute and thoughtful problem solver.
- This is a start-up environment. Flexibility, adaptability, resourcefulness and the ability to contribute to the development and/or validation of bioassay strategies and tactics will be important.
The QC Bioassay Analyst completes all QC Bioassay activities and documentation in compliance with applicable US and European cGMP regulations, corporate policies and company Standard Operating Procedures.
Specific responsibilities will include:
- Performs routine QC tests for product release, stability, and in-process monitoring
- Performs second analyst verification of assay results and raw data
- Provides input on QC Bioassay, procedures and cGMP issues including but not limited to flow cytometry, cell counting, ELISA, and PCR testing
- Participates in Bioassay analytical method transfer and validation
- Ensures timely issuance, review and approval of Bioassay testing results
- Executes method validation protocols
- Participates in selecting/qualifying analytical instruments as well as writing Test Methods and operational SOPs
- Troubleshoots unexpected events that occur during performance of the bioassay methods, method transfer, and method validation.
- Participates in laboratory deviation investigations and corrective and preventive actions
- Interfaces with colleagues to ensure effective CAPAs are implemented for recurring discrepancies
Targeted candidate will offer a related scientific degree and 3+ years of Bioassay experience in a biopharmaceutical company. Substantial experience with flow cytometry, ELISA, PCR testing and FACS is required.
Other priorities include:
- Experience developing and executing test methods for the Bioassay Laboratory
- Experience writing Standard Operating Procedures and Work Instructions
- Impeccable documentation habits
- Strong organizational skills, including the ability to juggle multiple projects and deadlines
- Longevity and impact in previous roles
Finally, we seek a collaborative and industrious professional who will thrive in this emerging and dynamic setting. A lot is happening. We seek an energetic and flexible analyst who will contribute broadly.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.
Local candidates only.