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. This role will be primarily located at our process development lab in South Brunswick, NJ, but the project responsibilities will require periodic travel to the GMP facility in Newark, NJ (roughly 20%). We are currently expanding our multidisciplinary team, seeking a Senior Scientist in Analytical Development to support our gene and cell therapy projects.
The responsibilities will include:
- Lead the development, optimization, and transfer of analytical assays for gene and cell therapy products.
- Complete analytical testing for process development studies of gene and cell therapies, including cell-based assays, molecular biology assays, and compendial assays.
- Oversee 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.
- Provide technical leadership on cross-functional project teams.
- Implement solutions to technical issues and participate in continuous improvement activities.
- Collate, analyze, and present data in internal and client-facing meetings.
- Conduct work cross-functionally on a variety of projects.
- Supervise junior scientists/research associates.
- Degree in Biotechnology, Biology, Biochemistry, Biotechnology, Molecular Biology, Biological Engineering, or an equivalent field with at least 3 years (Ph.D.), at least 5 years (M.S.), or at least 7 years (B.S.) with directly relevant experience.
- Experience with analytical assays used to characterize gene and cell therapy products (e.g. ddPCR, flow cytometry, ELISA, cell-based assays). Experience with analytical method development and qualification is a plus.
- At least 2 years of direct experience working with gene and/or cell therapies in an industrial setting is highly desired.
- Understanding of viral vector production and associated analytical assays. Direct experience with viral vector analytical assays is highly desired.
- Understanding of cell processing unit operations and associated analytical assays. Direct experience with cell therapy assays is highly desired.
- Experience working in a GMP environment and with the release of gene and cell therapy products is a plus.
- Competence in the implementation of safety requirements and a safety-first mindset.
- Strong verbal and written communication skills. Client-facing experience is a plus.
- An ability to identify, plan, and execute tasks independently.
- Enjoys working in a dynamic, fast-paced environment and possesses good communication skills.