BioCentriq is a Biologics CDMO specializing in Cell and Gene Therapy. Our team of expert scientists, engineers, operations and quality professionals, work 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 PD labs 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 Process Development Engineer to support our cell and ex-vivo gene therapy development and GMP manufacturing projects.
The responsibilities will include:
- Assessment of client processes and technology transfer activities into our GMP facility.
- Hands-on execution of the various aspects of enrichment, engineering, expansion, and formulation activities to support small-scale studies and process scale-up.
- Design experiments for process optimization and troubleshooting.
- Identify technical issues and implement solutions.
- Complete analytical testing for process development studies.
- Interpret and summarize data, present to client during meetings and in the form of technical reports.
- Transfer processes from PD lab to the GMP facility for Phase I/II manufacture.
- Coordinate with cross-functional departments on a variety of projects.
- B.S. Degree in Chemical or Biochemical Engineering or an equivalent field with 3-6 years of relevant industry experience, or similar M.S. Degree with 2-5 years of relevant industry experience
- Solid understanding of and hands-on experience in cell therapy manufacturing concepts.
- Experience working in a GMP environment. CDMO experience as plus.
- Experience with analytical assays (e.g. flow cytometry, ELISA).
- 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.