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 content of regulatory filings, design and management of nonclinical studies and being a technical resource for all stages of manufacturing development.
Essential Job Functions/Responsibilities
· Drafting, management and implementation of Standard Operating Procedures (SOPs) related to all aspects of GMP-Manufacture and clinical supply of cell therapies. Subject matter for SOP’s 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 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, including drafting specific components of the filing and close collaboration with Regulatory.
· Technical resource for all stages of development, including design and implementation of non-clinical studies, GMP compliant manufacturing, and GCP compliant clinical evaluation.
· Design and management of nonclinical studies to support development of cell and gene therapy products.
· Contribute technically to drug substance and drug product quality testing.
· Active communication and collaboration with other working groups, including Regulatory, Clinical, and Quality.
Desired Education & Qualifications
· BS Degree with 5+ years’ experience in cell and gene therapy or related field.
· MS Degree with 3+ years’ experience in cell and gene therapy or related field.
· Experience operating in GMP lab environment with Cell Therapy products.
· Experience with GMP-compliant manufacture of cell and gene therapy products.
· Experience with Regulatory filings, pertaining to cell and gene therapy products. Up to date understanding of current regulatory expectations and guidances.
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.