Process Engineer I/II
Role:
Be Biopharma is seeking a candidate to build the AAV Process Development (PD) department. Team members will work on early-stage process development of AAV. There are three major responsibilities within AAV PD- establish small scale AAV manufacturing methods to support R&D; develop mid-scale AAV manufacturing protocol to support the B cell drug product team; and tech-transfer AAV manufacturing protocols to support AAV cGMP manufacturing at CDMOs. Roles and responsibilities will be given based on experience and knowledge in the AAV or related filed. This is an excellent opportunity for career growth as you would interact with various programs teams and would be involved in regulatory document preparation.
Responsibilities:
- Develop process methods (upstream and downstream) to support small scale AAV6 manufacturing for R&D use
- Develop mid-scale methods to support large scale AAV6 manufacturing for pre-clinical use
- Perform upstream and downstream process development actives to improve yield and purity of AAV6
- Evaluate novel and emerging technologies to advance vector formulation
- Develop AAV vector analytical methods using various modern techniques (ddPCR, ACU, etc.)
- Validate AAV vector expression in B cells
- Collaborate with internal and external stakeholders
- Write and review technical documents including ELN entries, batch records, work instructions, SOPs, technical reports
- Work independently in a fast-paced environment
- Author and review 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 2-4 years of industry experience.
- Experience in scaling up and purifying AAV is highly preferred
- Proven experience in Design of Experiment (DoE) methodology and data analysis
- 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.
About Be Biopharma
Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. For more information, please visit us at Be.Bio and our LinkedIn page.
Culture
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.