Associate, Cell Therapy
POSITION OBJECTIVE: In this role, you will be responsible for contributing to the implementation and management of processes and appropriate quality controls related to manufacture of cell therapy materials. Additional responsibilities include contribution to standard operating procedures (SOPs) and content of regulatory filings and design and management of nonclinical studies. You will be a technical resource for all stages of manufacturing development, logistics, and clinical operations.
Essential Job Functions/Responsibilities
· Drafting, management, and implementation of SOPs related to virtually all aspects of GMP-Manufacture and clinical supply of cell therapies. Subject matter for SOPs may include manufacture of vectors, manufacture of cell products, assays and specifications for release testing, logistics, and handling of clinical samples.
· Oversight and planning related to process development and clinical supply.
· Familiarity with GMP regulations and planning/implementation of manufacturing site audits (vector and cell therapy).
· Active participation in preparation of regulatory filings related to cell therapies (e.g., USFDA IND applications). To include, drafting specific components of the filing and close collaboration with Athenex Regulatory/consultants.
· Technical resource for all stages of development, including design and implementation of non-clinical studies and GMP-compliant manufacturing to support cell therapy programs.
· Contribute technically to drug substance and drug product quality testing.
· Active communication and collaboration with other working groups, including Regulatory, Clinical, Logistics, and Quality.
Desired Education & Qualifications
· BS/MS Degree with 3-5 years’ experience in cell therapy or related field.
· Experience operating in GMP lab environment with cell therapy products.
· Excellent analytical skills, including quantitative and qualitative assessment skills and critical thinking skills.
· Excellent record keeping and documentation skills
· Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment
· Experience with regulatory filings, ex. INDs, pertaining to cell therapy products.
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.