Director/Senior Director Process Development

The successful candidate will be responsible for establishing and leading a Process Development group and strategy, as well as interacting with partners and CMOs to ensure alignment with our growing cell therapy portfolio.

This position is not an IT-oriented role. Only candidates with biologics, gene or cell therapy drug development experience need apply.

This position will be accountable for all cell therapy process development, clinical supplies, and product quality deliverables including process changes, comparability, process validation, expert support of operations and regulatory submissions. Interact extensively with internal and external partners in Analytical Development, Research, Quality, and Regulatory functions to develop project plans as well as ensuring that milestones and timelines are met. Maintaining a productive and positive culture of teamwork, mentorship, and scientific rigor will be expected to achieve the business needs for product development.

Responsibilities
• Implement and maintain manufacturing processes that supply clinical trials including troubleshooting, training and batch records
• Develop manufacturing strategies to meet business needs and project timelines
• Receive and adapt early phase processes to accommodate scale, GMP and regulatory requirements, quality, cost, and amounts necessary to implement clinical studies
• Ensure phase-appropriate GMP implementation throughout cell product development
• Supply product of acceptable quality for pre-clinical development studies and analytical method development
• Ensure a robust and reliable sourcing strategy for raw materials and ancillary supplies
• Form and lead a team of capable process development scientists and engineers
• Implement and maintain state-of-the-art developments key to cell therapy processing and production and ensure that manufacturing processes meet phase-appropriate and commercial requirements and desired characteristics
• Develop and implement changes that improve cost and quality of the manufacturing process appropriate to the development phase
• Design and execute comparability packages supporting the implementation of process changes
• Direct process characterization with an appropriate process control strategy
• Direct the process component of PPQ design to ensure successful execution
• Lead development, data generation, writing, and editing of product development and process related sections of regulatory submissions
• Direct the suitable study documentation and data verification

Skills/Knowledge Required
• Proven track record in process development. Strong technical qualifications including knowledge and application of engineering fundamentals
• Knowledge of regulatory standards applicable to cell therapy products, cGMP, quality standards as well as related biotechnology products and supplies required for GMP manufacturing
• Extensive cell culture expertise, as well as familiarity with underlying cell therapy immunobiology and common analytical methods; experience with iPSCs or related cells, is highly desirable
• Excellent leadership, communication, writing, and presentation skills

Experience
• Ph.D. in Biochemical Engineering or related discipline with 15+ years of biotechnology manufacturing, process engineering, technology transfer or technology management experience
• Previous experience with cell therapy products, cell culture, and aseptic processing is preferred
• Equipment development and qualification experience in a cGMP environment (IQ, OQ, PQ) along with process validation is preferred
• Proven track record of leading, developing and managing direct staff