Sr. Process Engineer / Principal Process Engineer, Process Development
Be Biopharma is seeking several candidates at various levels to build the Process Development (PD) department. Team members will work on early-stage process development of novel B cell autologous and allogeneic programs. There are four major responsibilities within PD- establish methods for B cell purification; engineer B cells using CRISPR-Cas9 mediated methods; develop methods for expansion/differentiation; and determine drug product formulation and cryopreservation methods. Roles and responsibilities will be given based on experience and knowledge in the cell therapy field. This is an excellent opportunity for career growth as you would interact with various programs teams and would be involved in regulatory document preparation.
- Establish process development capabilities- 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
- Develop and qualify a scale down model
- 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 science with 5-10 years of cell therapy experience or PhD in life sciences with 2-4 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.
Be Biopharma is pioneering a new class of medicines, unleashing the power of B cells to create the new field of Engineered B Cell Medicines. B cells are the body’s protein producing factories, most widely known for making antibodies. Our leading B cell therapy platform, developed by the top scientific KOLs in the field and with strong IP protection, harnesses this capability to engineer B cells to produce any protein with potential therapeutic application. This creates a unique opportunity to rapidly design and develop a broad portfolio of disease changing products (our platform affords ready swapping in new genes for different disease indications) and to significantly scale the company to realize substantial value in a short period of time.
Importantly, and in contrast to other cell therapy modalities, Engineered B Cells engraft naturally (and thus are not expected to require preconditioning chemotherapy). They are also “naturally allogeneic”, and we expect most or all of our portfolio to be “off-the-shelf” medicines. We have a rich pipeline of initial medicines under development in Oncology and Severe Genetic Disease, and we will subsequently expand to other important indications (e.g. Infectious Disease, Autoimmune Disease, etc).
Our Cambridge-based team is led by highly experienced, mission-driven executives all of whom are experienced cell therapy veterans who played key roles in developing several of today’s most impactful marketed gene and cell therapies. The team is rapidly expanding, with 20 employees joining in the first half of 2021. We are making major strides in our proof-of-concept studies for our lead programs in Oncology and Rare Disease, which are on track for near-term clinical development. Be Biopharma was founded in 2020 with a 52M Series A financing round supported by a syndicate of leading biotech investors (Longwood Fund, Atlas, RA Capital, Alta).
The beating heart of Be Bio is our People and together we are building a culture driven by purpose, passion, and that’s full of character. We are “all-in” as we align ourselves with patients who need our medicines, and we embrace the highest standards of transparency, excellence, candor, collaboration, and team-based science with a shared ownership of company milestones and successes.
Our commitment to our team members is to deliver a compelling, dynamic work experience that enables them to continually stretch, grow, and learn, that enriches their lives, that fosters a sense of belonging and community, and that goes above and beyond to support them in big, meaningful ways in both their personal and professional lives. Be Bio is a team that works hard, plays hard, and supports each other on our shared journey to get transformative medicines to patients who need them.