RA/ Sr. RA, Process Development (T-Cell Therapy)
Proclinical is currently recruiting for a RA/Senior RA of Process Development for a pharmaceutical company located in Cambridge, MA. Successful candidate will work closely with cross-functional teams to design, test, integrate & implement all processes and technologies related to chimeric antigen receptor T cells (CART).
- Perform studies to improve the identity, purity, and potency of cell product.
- Perform routine isolations of T cells and PBMC from primary donors.
- Support isolations of HSPCs from mobilized apheresis peripheral blood.
- Evaluate scale-up and close-system processes to ensure reproducibility of drug product.
- Draft documentation (protocols, batch records, reports) to standardize and transfer the Company's manufacturing processes to CMO.
- Establish tracking and trending analyses of process development, pilot and cGMP production runs.
- Assist in development related FMEA, as necessary.
- 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.
Skills and Requirements:
- 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 development.
- Ability to communicate effectively with strong communications skills and a collegial personality.
- Thrive and succeed in a team-oriented entrepreneurial environment.
- 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 LOVO, Sepax, CliniMACS Plus & Prodigy, bioreactors, or other cell therapy devices is preferred.
- cGMP experience in the cell and gene therapy space is preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646
or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.