Beam is seeking a highly energetic individual who has technical knowledge in Cell and Gene Therapy. The RA/Senior RA will work closely with cross-functional teams to design, test, integrate & implement all processes and technologies related to chimeric antigen receptor T cells (CART). In addition to technical expertise, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams, engage and collaborate with external partners in process development and manufacturing. Activities will include: 1) integration of biological processes which will increase the yield, purity, function, formulation, and storage of cell product; 2) scale-up, automate, and define process parameters; 3) assessment of equipment and processes to streamline and potentially close manufacturing of cell product; 4) integration of assays for in-process controls to monitor success of manufacturing runs; and 5) writing detailed procedures, test protocols, technology transfer documentation, and regulatory documents for clinical trials. This position will play an important role in developing the clinical manufacturing processes and analytical methods for developing cellular therapy products in the CART space. The primary focus of this position will be on CART, but flexibility to support occasional needs of hematopoietic stem & progenitor cells (HSPC) program will be necessary. The RA/Senior RA position is part of the Pharmaceutical Sciences team.
- Perform studies to improve the identity, purity, and potency of CART cell product.
- Perform routine isolations of T cells and PBMC from primary donors.
- Evaluate scale-up and close-system processes to ensure reproducibility of drug product.
- Draft documentation (protocols, batch records, reports) to standardize and transfer Beam’s manufacturing processes to
- Establish tracking and trending analyses of process development, pilot and cGMP production runs.
- Assist in development related FMEA, as
- Understanding of cGMP environment, and the use of Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification and validation.
- BS/MS in Life Sciences, Chemical, Mechanical, Bio-Engineering or related discipline.
- Corporate experience within biotech/pharmaceutical company or a CRO/CMO.
- Experience in cell-based therapy culture and process.
- Ability to communicate effectively with strong communications skills and a collegial personality.
- Thrive and succeed in a team-oriented entrepreneurial.
- Experience in T cell isolation, culture, and freezing is preferred.
- Strong candidates will have familiarity with flow cytometry and ELISA.
- Experience in automated cell processing systems such as Sepax, CliniMACS Prodigy & Plus, bioreactors, or other cell therapy processing instruments is preferred.
- cGMP experience in the cell and gene therapy space is preferred.