Contract - Sr. Specialist, Quality Operations

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. 

Be Bio is seeking a highly motivated Senior Specialist, Quality Operations, to join our Quality Assurance team. This new role will be a key leader, responsible for ensuring the success of our GMP manufacturing and quality control operations through oversight of our Contract Development and Manufacturing Organization (CDMO) partner. The successful candidate will play a critical role in technology transfer activities while also supporting daily external GMP quality operations.

Key Responsibilities:

• Partner closely with internal Manufacturing, MSAT, and AD/PD teams, and with external CDMO partners to provide GMP quality oversight, supporting Manufacturing and Quality Control activities.
• Act as a quality lead for technology transfer, collaborating closely with internal technical teams and the CDMO to ensure robust and compliant transfer of processes.
• Review and approve GMP documentation, including batch records, deviations, change controls, and CAPAs.
• Lead timely product disposition by ensuring all quality requirements are met.
• Partner internally to enhance the Be Bio Quality Management System and implement industry best practices.
• Travel to CDMO sites as needed (up to ~20%).
• 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 interpersonal and communication skills, ability to develop important relationships with colleagues, and being an all-around good company citizen are essential.

• Bachelor’s or Master’s degree in Life Sciences, or a related field.
• 5+ Experience in a GMP Quality Assurance manufacturing environment, with a focus on product disposition, deviation support, change control, and technology transfer.
• Strong knowledge of manufacturing processes, root cause analysis, and corrective action planning.
• Excellent communication and leadership skills, with the ability to coordinate cross-functional teams and manage relationships with CDMO partners.
• Ability to work independently and collaboratively in a dynamic environment.
• Demonstrated positive attitude and enthusiasm for problem-solving and overcoming challenges.
• This position will require up to 20% domestic travel during tech transfer activities to ensure proper oversight at the CDMO. After tech transfer is complete, travel requirements will reduce to < 10%.

Preferred Skills:

• 5+ years of experience supporting early phase cell therapy processes in a Quality Assurance role.
• Preferred experience in the development and transfer of early phase cell therapy processes.
• Preferred experience working with external CDMOs in a Quality Oversight capacity.
• Preferred experience drafting quality agreements.
• Familiarity with regulatory requirements for early-phase submissions and inspections.

At Be Bio, we recognize that our people are our most valuable resources, and we are committed to offering a competitive rate. The anticipated hourly pay range for this role is $48.00/hr - $55.00/hr, effective for the current calendar year and is subject to market changes. Final rate will be determined based on a range of considerations, including—but not limited to—location, experience, skills, and alignment with role responsibilities.