Sr. Principal Sci/AD, Analytical Development

Sr. Principal Sci / AD, Analytical Development

Role: 

The leader will be responsible for technical planning, and execution of analytical development activities for release and characterization assays using advanced flow cytometry tools as well as initiating development of potency assays.  You will drive new method development, existing method optimization and the corresponding testing. You will drive appropriate analytical technical strategies to increase our process and product understanding while collaborating with research and process development teams and leverage resources across Be Bio. The role includes establishing and executing efficient processes and procedures including sample testing, data management, report writing, and documentation for important studies. Support method prequalification data generation, manufacturing assay troubleshooting, root cause investigation, and support tech transfer of processes to manufacturing by liaising with MSAT and Quality for RESL facing activities. This is a great opportunity to develop and mentor a high-performing team of scientists that will require hands-on work to instruct and build the necessary skills within the group while leading day-to-day group activities including timeline and budget management and objective setting and execution.

Responsibilities:

• Apply advanced scientific principles, theories, concepts, practices and standards to analytical development of release and characterization assays using advanced flow cytometry tools
• Lead a team of scientists to develop comprehensive analytical understanding of cell surface markers in pre-clinical and clinical development. Support routine testing for prioritized assays and projects
• Develop technical strategy for potency assay for novel B cell medicines and initiate proof of concept development aligned with program priorities
• Ensure consistent method development and data generation supporting aligned priorities
• Assure appropriate laboratory controls and procedures for training, sample management, data integrity, reagent and equipment
• Author method development and qualification reports and test methods. Support evaluation of suitability of new methods and oversee method prequalification activities on-site
• Hire and mentor staff and champion inclusive culture
• Demonstrate care and appreciation for staff as a foundation for developing an exceptional team

Experience, Education, Specialized Knowledge, and Skills:

Must thrive in a fast-paced, growing, and innovative environment with changing priorities where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal skills, ability to develop important relationships and open communication with your stakeholders, and being an all around good company citizen are essential.

• Ph.D. in a relevant, scientific field, with 8+ years of relevant industry experience. BS or MS degree, and 12+ years of relevant industry experience
• Strong technical background as demonstrated by supporting the development of multiple therapeutic candidates.
• Advanced hands-on experience with various analytical techniques, especially advanced flow cytometry and potency assays for cell therapy
• Demonstrated understanding developing analytical methods in compliance with ICH
• In-depth understanding of Regulatory Guidelines in technical oversight of analytical development would be an added advantage. Experience with CMC regulatory filings
• Experience preparing technical documents for internal distribution or inclusion in regulatory filings
• Excellent communication, technical writing, and presentation skills settings and actively participate in departmental meetings as well as cross-functional area project teams
• Exceptional teamwork and interpersonal skills with the ability to motivate others, influence, and negotiate difficult situations
• Demonstrated experience building and leading exceptional teams and prioritize and balance work from multiple individuals in the team

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’