POSITION OBJECTIVE: As a Director of Cellular Manufacturing you will lead manufacturing efforts related to cell-based therapies. This position will be responsible for translating technologies from preclinical to clinical stage of development. This role will involve the development, tech-transfer, qualification and validation of processes and methods associated with vector drug substance manufacture as well as cell product manufacture using internal and external resources in compliance with relevant regulations. Additionally, close collaboration with clinical team and sites for coordination of clinical supplies is essential.
Essential Job Functions/Responsibilities
· Lead CMC development, manufacturing, quality, and supply chain projects to support the development of clinical operations.
· Establish project plans and timelines for process development, process technology transfer and GMP manufacturing for T cell therapy development projects.
· Manage the process development of cellular manufacturing for a first-in-human cell therapy clinical trial.
· Work closely with our research teams to scale processes and translate protocols to GMP.
· Create and review technical and scientific documents including Master Batch Records, reports, and SOPs.
· Design experiments for process development including operation of related equipment, DOE, process scale-up, and appropriate analytical testing.
· Work closely with and manage CROs and CMOs in cellular manufacturing and analytical development.
· Write detailed reports and CMC documentation to support regulatory filings.
· Determine need for new or updated methodology and direct development and validation of new methods of production, associated quality control assays, and all associated standard operating procedures (SOP), master process records and staff training programs.
· Coordinate and oversee inspections by regulatory authorities.
Required Education & Qualifications
· MS, or Ph.D. in biology, chemical biology, biochemistry or related area with minimum 5+ years of direct experience in cellular therapy CMC.
· Proven proficiency with GTP, GLP, GMP and GCP.
· Demonstrated hands-on experience with cellular manufacturing and a deep understanding of CMC related to cell therapies.
· Experience with process scale-up.
· Experience with closed, automated manufacturing systems.
· Experience with and a strong background in cell culture.
· Experience and knowledge of the immune system.
· Experience in T cell biology, tumor immunology, and other immune components.
· Knowledge of compliance and quality management systems.
· Knowledge of flow cytometry and T cell phenotyping.
· Experience with cell transfection and transduction systems.
· Highly motivated, creative, and devoted to project goals.
· Strong communication and collaboration skills.
· Able to contribute in a meaningful way to scientific discourse.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.