Senior Research Associate, Analytical Development (South Brunswick, NJ)
Description
BioCentriq is a Biologics CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations, and quality professionals works with our clients to translate groundbreaking treatments into the clinic. The novel therapeutics we focus on require constant innovation and creative thinking for the clinical translation and subsequent GMP manufacturing to be successful. The BioCentriq state-of-the-art facility includes process development laboratories as well as clean room space to support Phase I/II clinical projects of our clients.
We are currently expanding our multidisciplinary team, seeking a Senior Research Associate in Gene and Cell Therapy Analytical Development to support our gene and cell therapy projects. This role will be primarily located at our process development lab in South Brunswick, NJ, but the project responsibilities may require periodic travel to our GMP facility in Newark, NJ (roughly 10%). The responsibilities will include:
- Complete analytical testing for process development studies of gene and cell therapies, including cell-based assays, molecular biology assays, protein assays, and compendial assays.
- Support the development, optimization, and transfer of analytical assays for gene and cell therapy products.
- Support in-house analytical testing and the outsourcing of analytical assays to external contract organizations.
- Assist with the assessment of client processes and technology transfer activities.
- Support the technical review and authorship of technical reports, SOPs, and GMP documentation.
- Identify technical issues and implement solutions.
- Collate, analyze, and present data in internal and client-facing meetings.
- Conduct work cross-functionally on a variety of projects.
Requirements
The successful candidate will have the following skills:
- Degree in Biotechnology, Biology, Biochemistry, Chemistry, Biotechnology, Molecular Biology, Biological Engineering, or an equivalent field with at least 1-2 years (M.S.), or 2-5 years (B.S.) of directly relevant experience.
- Experience with analytical assays used to characterize gene and cell therapy products (e.g. ddPCR, qPCR, flow cytometry, ELISA, cell-based assays). Experience with analytical method development and qualification is a plus.
- Understanding of cell processing, viral vector production, and associated analytical assays. Direct experience with cell therapy and/or viral vector analytical assays is highly desired.
- Experience working in a GMP environment and/or with the release of gene and cell therapy products is a plus.
- Strong verbal and written communication skills. Client-facing experience is a plus.
- Competence in the implementation of safety requirements and a safety-first mindset.
- An ability to identify, plan, and execute tasks independently.
- Enjoys working in a dynamic, fast-paced environment and possesses good communication skills.