Senior Engineer, Gene Therapy Process 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 Engineer in Gene Therapy Process Development to support our gene therapy projects. This role will be primarily located at our process development lab in South Brunswick, NJ, but the project responsibilities will require periodic travel to our GMP facility in Newark, NJ (roughly 10-20%). The responsibilities will include:
- Assessment of client processes for gene therapy projects.
- Lead technology transfer activities into our process development and GMP facilities.
- Development of scalable upstream and downstream processes for viral vectors and biologics.
- Hands-on execution of the various aspects of downstream bioprocessing, including chromatography purification, filtration, and formulation activities to support small-scale studies and process scale-up.
- Lead the design experiments for process scale-up, process optimization, and troubleshooting.
- Identify technical issues and implement solutions.
- Support analytical testing for process development studies.
- Lead the transfer processes from PD lab to the GMP facility for manufacture.
- Analyze, interpret, and summarize data, and present it to client during meetings and in the form of technical reports.
- Coordinate with cross-functional departments on a variety of projects.
Requirements
The successful candidate will have the following skills:
- Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or an equivalent field with at least 3-5 years (Ph.D.), 5-7 years (M.S.), or 7-10 years (B.S.) of relevant industry experience.
- Solid understanding of and hands-on experience with viral vector manufacturing concepts.
- Experience with the development and hands-on execution of upstream processes for viral vector production, including adherent and suspension bioreactor cell cultures.
- Experience with the development and hands-on execution of downstream processes for viral vectors, including chromatography, tangential flow filtration, and/or ultracentrifugation.
- Experience working in a GMP environment. CDMO experience as plus.
- Experience with analytical assays (e.g. flow cytometry, ELISA) 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.
- High level of independence.
- Experience with the management of projects.
- Enjoys working in a dynamic, fast-paced environment and possesses good communication skills.