Beam is seeking a highly energetic individual who has technical knowledge in Analytical Development for Cell Therapy. The Scientist II/Senior Scientist will work closely with the Cell Process Development team to design, test, integrate & implement all analytical assays related to Beam’s Cell Therapy candidates, including chimeric antigen receptor T cells (CART) and CD34+ HSC programs. In addition to technical expertise, the candidate should also possess the ability to interface with multidisciplinary teams, engage and collaborate with external partners in assay development for cell therapy manufacturing. Activities will include: 1) development, design, and implementation of assays at various cell processing stages for in-process control, release criteria, and for-information-only; 2) representing CART and HSC analytics across program teams and externally to CMO and vendors; 3) management of project timelines and deliverables, including the coordination of work with key stakeholders; 4) provide technical leadership to project teams and leverage expertise in analytical assays to ensure project success; and 5) writing detailed procedures, test protocols, technology transfer documentation, and regulatory documents for Pre-IND and IND filing. Familiarity with FACS, qPCR, ELISA, and co-culture-based assays are required. This position will play an important role in development of analytical assays for cell therapy products. Flexibility and collaboration are required to engage across all functional teams across beam and with external manufacturing partners. The Scientist/Senior Scientist position is part of the Cell Process Development team within the Pharmaceutical Sciences group.
- Identify required analytics and target range for characterization of CART and HSC products.
- Independently plan, execute, analyze, and report assay development and qualification studies.
- Lead the collection, interpretation, and communication of data for a variety of analytical methods across teams.
- Provide technical expertise and leadership within project teams.
- Draft documentation (protocols, batch records, reports) to standardize and transfer Beam’s analytical methods to
- Establish tracking and trending analyses of process development, pilot and cGMP production runs.
- Analyze development and manufacturing data to assist in the development of a cGMP cell process.
- 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.
- MS/PhD in Life Sciences, 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 analytical development experience.
- Ability to communicate effectively with strong oral and verbal communications skills and a collegial personality.
- Familiarity with FACS, ELISA, and qPCR.
- Thrive and succeed in a team-oriented entrepreneurial
- Familiarity with IncuCyte and NGS assays.
- CMC regulatory knowledge and cGMP experience in the cell and gene therapy space.
- Good understanding of current regulatory landscape for Ex-Vivo approaches.