Process Engineer I/II, Process Development

Role:
Be Biopharma is seeking several candidates at various levels to build the Process Development (PD) department. Team members will work on process development of novel B cell autologous and allogeneic programs. The major responsibilities within this role are to optimize B cell purification, streamline gene editing of B cells using CRISPR-Cas9 mediated methods, scale up expansion and automate cell culture, and determine drug product formulation. As part of a growing company, our team is looking for candidates from individual contributors to potential small team leads. Specific responsibilities will be determined based on experience and knowledge in the cell therapy field with commensurate leveling. This is an excellent opportunity for career growth as you would interact with various program teams and would be involved in regulatory document preparation.

Responsibilities:

• Optimize process performance: isolation, activation, gene-engineering, expansion, and differentiation of B cells
• In scale down model, test various media and raw materials for optimal B cell growth and expansion
• Develop, optimize, and scale up a robust cell manufacturing process to support IND enabling studies and GMP manufacturing
• Contribute to internal engineering activities: automated cell washing, electroporation systems, perfusion, controlled rate freezing systems, culture expansion, and cryopreservation systems
• Design, conduct, and interpret process development and process optimization experiments
• Design, conduct, and interpret process characterization experiments
• Author and review of technical documentation to support early-stage activities as well as draft manufacturing documentation to support tech transfer
• Collaborate closely with manufacturing to tech transfer the developed process to a GMP facility

Experience, Education, Specialized Knowledge, and Skills:

• BS or MS in Chemical Engineering, Biology, Analytical Chemistry, Biochemistry, Cell & Molecular Biology, or related discipline with 0-2 years of industry experience.
• Hands-on experience with various cell isolation, expansion, gene-delivery, and cryo-preservation instruments; good knowledge of close-processing and CRISPR-Cas9 mediated cell engineering
• Experience in writing technical documents including development technical reports
• Excellent communication and presentation skills with the proven ability to solve complex problems and to work effectively as a member of a multidisciplinary team, detail oriented, and critical thinker.
• Ability to use literature to design proof of concept studies.