QC Support, Analytical Testing (PCR, ELISA, Flow Cytometry) – Contractor/Top $$
Our client, a Raleigh area company that is developing and manufacturing gene-based therapies for the treatment of a variety of life-altering illnesses, is actively recruiting for 2-3 contractors to join its Quality Control team.
This is an outstanding foot-in the-door with a company that is manufacturing industry-changing gene therapies.
These are immediate needs expected to last ~ 6 months. Long-term potential may exist for top-performing candidates. Company will pay top dollar to retain strong candidates.
Key things to note:
- This is a clinical phase biotech and these Scientists will participate in all daily bioanalytical activities including Polymerase Chain Reaction (PCR), flow cytometry, cell counting, ELISA testing, etc. Familiarity with these techniques will be important.
- Roles will involve supporting method development, qualification, validation and GMP release testing for process intermediates, drug substance and finished product.
- This is a highly collaborative environment and we seek candidates who enjoy working in a team.
- Works will be performed on-site at the company’s North Raleigh facility. Strict COVID-protection policies are enforced.
- This company is in start-up mode, whereby policies and practices are still being developed and priorities change often. Flexibility, adaptability, resourcefulness and ingenuity will all be important.
The QC Scientists complete 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
- Tests process intermediates, drug substance and drug product according to specifications
- Participates in Bioassay analytical method development, qualification, and validation.
- Supports investigations to determine root cause of OOS and other non-conforming results and implements appropriate corrective and preventative actions.
- Maintains supply of lab materials, reagents, and consumables
- Authors and trains on SOPs, protocols, and technical reports.
- Liaises with other departments including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs.
- Participates in laboratory deviation investigations and corrective and preventive actions
- Interfaces with colleagues to ensure effective CAPAs are implemented for recurring discrepancies
Targeted candidates will offer a related scientific degree and 1+ years of Bioassay experience in a biopharmaceutical setting (internships and lab experiences included). Experience with PCR testing, flow cytometry, ELISA, and FACS will be important.
Other priorities include:
- Experience executing test methods for the Bioassay Laboratory
- Experience adhering to Standard Operating Procedures and Work Instructions
- Impeccable documentation habits
- Strong organizational skills, including the ability to juggle multiple projects and deadlines
Finally, we seek a collaborative and industrious candidate who will thrive in this dynamic setting. A lot is happening. We seek an energetic and flexible scientist who will contribute broadly.
Please forward Word resume for prompt consideration.
Local candidates only.