QC Bioassay Supervisor, Raleigh Biotech – Top $$
Our client, a clinical phase biotechnology company in the gene therapy space, is actively recruiting for a very sharp and knowledgeable candidate for its Quality Control Bioassay Supervisor role. The company is in the process of building out its primary production facility in North Raleigh and this Bioassay Supervisor will lead the development and implementation of all 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 supervisor will oversee the daily QC Bioassay activities including flow cytometry, cell counting and Polymerase Chain Reaction (PCR) testing. Substantial experience in noted techniques is required.
- This supervisor will also be responsible for ensuring compliance and clean documentation. We seek a candidate who is meticulous regarding quality and follow-up.
- This is a start-up environment. Ability to contribute to the development of bioassay strategies and tactics will be important. Extensive experience with method development and method validation is expected
- Position will require overseas travel for training.
This QC Bioassay Supervisor will oversee all Bioassay activities ensuring completion and compliance. S/he will also work with leadership and other departments to identify and implement process improvements.
Specific responsibilities will include:
- Hires, develops, trains and evaluates QC Bioassay personnel
- Authors Test Methods and Method Validation/Transfer Protocols and Reports
- Ensures and promotes compliance with applicable US and European CGMP regulations, corporate policies and SOPs
- Provides input on QC Bioassay procedures and CGMP issues including flow cytometry, cell counting, and PCR testing
- Develops Bioassay analytical methods as needed
- Ensures timely issuance, review and approval of Bioassay testing results
- Evaluates and investigates lab deviations. Initiates and coordinates corrective and preventive actions as required
- Ensures effective corrective and preventive actions are implemented for any recurring product/process discrepancies
- Maintains systems to track and trend key Quality Indicators and ensure KPIs are addressed. Assures that any adverse trends or patterns are noted and are promptly addressed
Targeted candidate will offer a related scientific degree and 5+ years of Bioassay experience in a biopharmaceutical company. Substantial experience with flow cytometry and FACS is required. Other priorities include:
- Experience developing test methods for the Bioassay Laboratory including suitability studies for compendial methods and method validation for non-compendial methods.
- Experience writing Standard Operating Procedures and Work Instructions
- Experience choosing equipment and instrumentation for the Bioassay Laboratory
- Supervisory experience as well as experience overseeing the work of contract labs
- Knowledge of current global initiatives including Quality by Design, Process Validation and Data Integrity
- Longevity and impact in previous roles
Finally, we seek a highly collaborative and industrious professional who will thrive in this emerging and dynamic setting. A lot is happening. We seek an energetic and mission-driven builder who will contribute broadly.
This is an immediate need and a Direct Hire opportunity. Please forward Word resume for prompt consideration.
Local candidates only.