Sr. Engineer II (Tech Transfer Lead), MSAT

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCM) 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. 

We are looking for a hands-on leader to own the transfer of our cell therapy processes and analytical methods to a CDMO partner. This role is about learning the science in our process development lab, translating it into phase-appropriate, scalable operations, and ensuring the CDMO can run successfully. You’ll be the point person for tech transfer, driving alignment across process and analytical development, MSAT, Quality, and CDMO teams to move our programs into clinic. This role will transition into a clinical facing technical support role along with clinical start up after the transfer is complete.

Responsibilities

• Hands-on learning: Build practical knowledge of our platform by working directly in the development lab with development counterparts. Develop expertise in processing equipment, workflows, and assays in order to deliver successful technology transfer.
• Tech Transfer Documentation Ownership: Prepare and review tech transfer documents including process descriptions, sampling plans, stability protocols, operator training materials, risk assessments, study protocols, and data packages.
• Cross-functional leadership: Work closely with project management support to lead the tech transfer team with clear timelines, deliverables, risk registers, and escalation pathways; coordinate inputs across Development, MSAT, and Quality.
• Analytical Method Transfer: Own process and analytical method transfer from internal PD lab to CDMO, ensuring readiness for engineering and GMP runs.
• End-to-end Transfer Ownership: Ownership of tech transfer project from initial project kick-off through clinical start-up at the CDMO.
• On-the-floor oversight: Provide technical coverage during CDMO engineering and GMP runs; act as Person in Plant (PiP) to troubleshoot, align stakeholders, and drive on-time execution.
• Issue resolution: Lead transfer related investigations using root cause analysis tools and draft CAPAs to correct.
• CDMO partnership: Develop strong working relationships with CDMO technical leads; create joint ownership of deliverables and ensure transparent, timely communication.
• Be Awesome: Exhibit a positive attitude and a proactive approach to problem-solving, embracing challenges with enthusiasm and a solutions-oriented mindset.

Minimum Experience, Education, and Specialized Knowledge and Skills:

Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpe