Be Biopharma is seeking an experienced Sr. Manager/AD of Cellular Analytical Development to help build and lead analytical operations in support of product characterization and product release of various drug products. The successful candidate will a technical and strategic leader to support in-process and final drug release testing of engineered B cells. This leader will spearhead the drug development activities in collaboration with various functions within TechOps and file one-to-two IND per year. The successful candidate must have demonstrated leadership capabilities in leading Analytical teams.
- Provide leadership to the Analytical Development (AD) team, including day-to-day staff management.
- Provide technical leadership to the AD teams responsible for various immunological and molecular assays
- Provide leadership to various groups within AD- Raw material and residuals, molecular analytics, Immunophenotyping, Potency
- Author, review and approve tech reports, qualification/validation protocols, test methods and batch records
- Demonstrate outstanding technical acumen, operational understanding, and cGMP compliance
- Critically contribute to process/product characterization efforts
- Hire and mentor Cell Therapy AD staff and champion inclusive culture
- Demonstrate care and appreciation for staff as a foundation for developing an exceptional team
- Establish and effectively manage department annual operating budgets
- Work with peers in other Technical Operations groups as well as Research, Clinical, and regulatory to develop a robust, integrated approach to therapeutic development
- Lead the effort to complete all regulatory documents (briefing documents, IND, and BLA filing)
- Work closely with the Research department to ensure consistency in assays across the organization
Experience, Education, 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 skills, ability to develop important relationships with your stakeholders, and being an all around good company citizen are essential.
- Ph.D. with 10+ years of industry experience, Bachelor’s degree, and 15+ years of direct experience in Analytical development of cell therapies, drug products, or biologics
- Exceptional teamwork skills
- Excellent communication, technical writing, and presentation skills
- Strong technical background in Analytical development as demonstrated by supporting the development of multiple therapeutic candidates
- Experience with CMC regulatory filings
- Demonstrated experience building and leading exceptional teams
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.