Beam is seeking a highly energetic individual who has deep technical knowledge in Cell and Gene Therapy space. The Scientist/Sr Scientist will work closely with the Hematology team to design, test, integrate & implement all processes and technologies related to hematopoietic stem & progenitor cells (HSPC). 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 isolation of HSPC; 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. The Scientist/Sr Scientist will actively train, assist and monitor CMO staff during the tech transfer and implementation of production at the CMO. This position will play an important role in developing the clinical manufacturing processes and analytical methods for developing cellular therapy product.
- Perform studies to improve the identity, purity, and potency of cell product.
- Perform 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 project management to determine development activities, technology transfer activities, timelines and resource needs to meet corporate goals.
- Assist in development related FMEA, as
- Good 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.
- PhD/MS in Life Sciences, Chemical, Mechanical, Bio-Engineering or related discipline.
- 3 or more years corporate experience within biotech/pharmaceutical company or a CRO/CMO.
- Experience in cell-based therapy culture and process development experience.
- Ability to communicate effectively with strong oral and verbal communications skills and a collegial personality.
- Ability to travel for multiple day assignments at CMOs.
- Familiarity with statistical software analyses.
- Thrive and succeed in a team-oriented entrepreneurial
- Experience in HSPC isolation, culture and differentiation is preferred.
- Experience in automated cell processing systems such as LOVO, Sepax, CliniMACS Plus & Prodigy is preferred.
- CMC regulatory knowledge and cGMP experience in the cell and gene therapy space is preferred.
- Good understanding of current regulatory landscape for Ex-Vivo approaches is preferred.