The Director of Bioanalysis for B Cell Therapy is responsible for building and leading a team of scientists to develop bioanalytical plans and be involved in the design, development, qualification, and validation of quantitative assays supporting B cell therapy research and development. This is an exciting opportunity at Be Bio, which is creating a bold new class of cell therapies and is advancing B cell therapy to clinic.
Role & Responsibilities:
- Build up our bioanalytical capability to support B cell therapy programs at both research and development stages
- Builds and retains a team of high-performing scientists & RAs that can realize the company’s goals
- Act as the subject matter expert (SME) in protein assays (e.g., LC-MS, ELISA), molecular assays (e.g., qPCR, ddPCR etc.), and cellular assays (e.g., flow cytometry, ELISpot etc.) development, qualification, and validation
- Be involved in the design, development, qualification, and validation of quantitative assays supporting B cell therapy programs from research to clinic.
- Develop internal guidelines for bioanalytical method development and ruggedness evaluation of assay in support of in vivo studies
- Identify CROs, oversee method development in house or at identified CROs, method transfer and method validation at CROs. Ensures bioanalytical method development is performed with a level of rigor and validation appropriate for stage of research and development ensuring compliance with internal guidelines, SOPs and regulatory guidelines.
- Review data for scientific rigor and ensure project compliance with external regulatory requirements and internal guidelines
- Review and approve method qualification/validation reports and sample analysis reports.
- Drive innovation within Bioanalysis and keep up to date of new technologies and instrumentation for implementation of new experimental strategies.
- The ability to deliver clear, concise, and persuasive oral, and written communications is required.
- Key interdepartmental collaborations will include Research, Technical Operation, and Clinical group to ensure adequate and timely bioanalytical support of non-GLP and GLP preclinical and clinical studies.
- Maintain and support safe lab practices and environment.
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. Demonstrated ability to manage a high-performing team where collaboration and innovation are essential.
- Ph.D. or Master’s degree in biology, immunology, chemistry, pharmacology, or related scientific fields required with 10+ years' relevant experience.
- Demonstrated experience and expertise in developing and establishing bioanalytical methods to support cell and gene therapy programs
- Strong background in protein assays (e.g., LC-MS, ELISA), molecular techniques (qPCR, ddPCR etc.) and cellular assays such as flow cytometry, ELISpot etc.
- Knowledge of current regulatory guidance and industry best practices in cell and gene therapy bioanalysis
- Familiar with requirements of FDA/EMA, GLP/GCLP regulations, and ICH guidelines.
- Great leadership experience in both project and people management is required.
- Ability to achieve objectives/timelines through collaborative efforts with coworkers, managers, and CROs.
- Ability to work independently and have good attention to the details.
- Background in B cell biology/immunology highly desirable
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.
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.