Associate Scientist (QC Testing/PCR, ELISA) – RTP Gene Therapy/Contract to Start
Our client, an RTP area biopharma that is developing cutting edge therapies for the treatment of rare genetic diseases and cancers with a strong genetic component, is actively recruiting for a skilled and can-do candidate to join its R&D team.
This Scientist will be part of the CMC Analytical team and be responsible for running routine tests in support of the optimization of GMP processes. We seek a candidate who enjoys lab work and who will diligently and impeccably conduct and document their work. Experience with PCR, ELISA and similar techniques in a cGMP-regulated setting will be important.
Other Things to Note:
- This position will begin as a one-year contract, with potential for extension and/or long-term hire. This position will be on-site at its Raleigh lab.
- Role will involve executing assay and testing activities of AAV-based gene therapies to enable their cGMP production and release. QC experience in a cGMP setting will be important.
- Although industry experience in gene therapy is preferred, client will also consider top recent grads with some knowledge (through internships) of QC/GMP testing.
- This is an emerging environment with a pitch-in-where-you-can culture. Seek flexible and versatile candidate who enjoys a collaborative, high energy, low drama setting.
The position will involve sample analysis in support of the optimization and development of cGMP processes for the manufacture of AAV-based gene therapies as well as assisting in the development of new assays and techniques to further define and assess their gene therapy vectors.
- Perform routine experiments: qPCR, ddPCR, SDS-PAGE and ELISA.
- Assist with data acquisition and data analysis.
- Generate timely analytical test results regarding the quality attributes of both in-process and final drug substance materials.
- Contribute to technical reports, work instructions, standard operating procedures, and qualification/validation protocols.
- Support laboratory operations including instrument maintenance and supplies management.
- Ensure all experimental procedures and documentation are compliant with highest quality and regulatory standards.
- Document experimental data, results, and conclusions in an electronic laboratory notebook.
Targeted candidate will offer a BS/MS scientific degree and 1+ years of experience with QC testing in a cGMP-regulated setting.
Other priorities include:
- Experience and working knowledge with some or most of the following assays: ELISA, qPCR/ddPCR, Spectrophotometry, Gel Electrophoresis
- Ability to troubleshoot instrumentation and analytical test methods
- Strong documentation skills
- Keen attention to detail
- Excellent written and verbal communication skills
Finally, we seek a sharp and focused team player who is level-headed, reliable and eager to contribute to the shared goals. There is a lot happening and priorities shift daily. We seek a self-motivated and get-things-done candidate who will thrive.
This is an immediate need. Please forward Word resume for prompt consideration. Local candidates only.