Director - Analytical Tech Transfer Lead

As part of BlueRock's vision to change the future of medicine by enabling ground-breaking cell therapies, we’re looking for a Director, specialized in Cell Therapy, to lead analytical transfers of a dynamic and progressive Bluerock Portfolio. The position requires a data driven scientist with an analytical mindset who has great communication skills to operate in a cross-functional team environment. This role will provide scientific, and technical oversight for analytical method transfers, method implementations and remediations, validations, and establishment of execution excellence with compliant with established analytical control strategies.

Reporting to the VP of AST&QC, the Associate Director/ Director will be a key technical leader of an analytical team supporting our commitments to product quality of cell-based therapeutics destined for human clinical trials, from starting pluripotent stem cell materials to final differentiated cell therapy in Berkeley, California.

The successful candidate will drive the execution of analytical strategy in a GMP-compliant environment, enabling method equivalence and life cycle strategies, comparability studies for process changes, studies to support regulatory commitments, and providing investigational testing for method remediations.

This is an exciting opportunity for a highly motivated leader capable leading a matrix team, and leading from the bench in technically complex methods when needed, to solve a wide range of challenging problems in creative and practical ways with a collaborative approach across a matrix of functional groups. 

Responsibilities:

• Lead transfer of analytical strategies to ensure the product quality of cell banks, intermediates, drug substance and drug products of BlueRock Portfolio.
• Lead and liaise with project teams to perform testing for the evaluation and/or characterization of cell therapies, including investigational testing.
• Drive and champion evaluating and implementing new technologies, processes, and analytical methods critical to safety and quality for cellular therapeutics.
• Direct and manage the execution of multi-site analytical strategies supporting regulatory filing requirements in compliance with Quality standards.
• Lead matrix teams to facilitate analysis of multiple data sources for various assays, tracking and trending data as required.
• Document experimental data in a timely and accurate manner following good documentation practices and in accordance with the company quality management system.
• Follow good documentation practices to author, review and approve SOPs, study protocols, reports, and other technical documents.
• Prepare and present scientific data and technical information internally and externally as required.
• Establish and/or act as subject matter expert to support training of specialists in test methods and analytical instruments.
• Provide scientific and technical mentorship to junior staff.

Minimum Requirements:

• Minimum of a Ph.D. in Biological Sciences, or related field with a minimum of 10+ years of experience in academia and/or industry is required OR a Master’s Degree with 15+ relevant experience is required. 
• Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.
• Highly familiar with standard testing procedures and an in-depth knowledge of analytical methods and equipment including, but not limited to:
• Flow cytometry, cell-based potency and screening assays, DNA/RNA analysis (extraction, QPCR, RT-QPCR, ddPCR), sterility, genomic stability, identity, and residual analysis.
• A solid understanding of aseptic techniques and technologies in cell culture is required.
• Demonstrated experience in technology transfer and qualification or validation of biological assays is a must.
• Successful supervisory and mentoring skills in leading scientific and technical staff is desired.
• Experience with Good Documentation Practices and working in a cGMP or equivalent environment is required.
• Excellent written and oral communication skills, with strong organizational and problem-solving skills and keen attention to detail.
• Working knowledge of statistics and data trending using statistical programs and software is preferred.
• Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
• This position will require some Travel.

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