The Sr. Director of Process Development will be responsible for executing a strategic vision to enable successful manufacturing processes and operations of NK cell therapies from early development through clinical and commercial marketing applications. This position will execute a life cycle approach to Process Development that includes risk and quality-driven product and process understanding, QbD approaches to process design and characterization, and well-defined analytical control strategies.
This individual will be supporting Process Design, Analytical Development, Tech Transfer, Process Validation, Process Comparability, and MSAT. They will deliver on commitments, while maintaining a culture of teamwork, mentorship, scientific rigor, and serving the business needs. This person will be responsible for the PD project portfolio.
The person will be accountable for CMC deliverables including process changes, comparability, process validation, SME support of operations, regulatory submissions, and handoff to clinical and commercial manufacturing teams.
This individual will build strong relationships and interact extensively with Research, Manufacturing, Quality, and Regulatory functions to ensure project milestones and timelines are met.
- Implement and support manufacturing processes that supply clinical trials
- Receive and adapt early phase processes to accommodate scale, GMP and regulatory requirements, cost, and efficiencies necessary to implement a Phase 1 study
- Develop and execute manufacturing strategies to meet business needs and project timelines
- Provide development input to guide potential new pipeline product candidates towards GMP products
- Update manufacturing processes towards commercial requirements and desired characteristics
- Conceive, develop, and implement changes that improve cost, labor, or quality of the manufacturing process for products in development or commercial stages
- Demonstrate appropriate fit for developed manufacturing technologies
- Design and execute comparability packages supporting the implementation of process changes
- Provide technical support (MSAT) to clinical manufacturing as well as technology transfer to clinical and commercial facilities including troubleshooting, training, and batch record writing
- Generate the technical components of cellular immunotherapy process validation packages
- Support the generation of process characterization data and understanding along with appropriate process control strategy
- Support the process component of PPQ design and collaborate with manufacturing teams to ensure successful execution
- Support development, data generation, writing, and editing of CMC sections of regulatory submissions
- Support strategy and plans in discussion with Regulatory Authorities and consultants
- Support the suitable study documentation and data verification
- Supply product of appropriate quality for pre-clinical studies, analytical development, and any other non-clinical needs
- Maintain and spread knowledge of current scientific literature and leverage key developments
Maintain a culture of mentorship, teamwork, passion for the patient, and scientific rigor
*The company reserves the right to add or change duties at any time.
- Strong technical qualifications including knowledge and application of process development fundamentals
- Knowledge of regulatory standards applicable to cellular products, the developing cellular immunotherapy field, and GMPs
- Extensive cell culture expertise as well as familiarity with underlying NK cell therapy immunobiology and common analytical methods
- Excellent leadership, communication, writing, and presentation skills
- Education: B.S in Biology, Engineering or related discipline with 5+ yrs cell therapy / process development experience