Philadelphia, Pennsylvania, 19107
Job description
The Director/Executive Director is responsible for spearheading the global regulatory chemistry, manufacturing, and controls (CMC) strategy and implementation for cell and gene therapy initiatives from the initial development phase to product licensing. This role involves acting as the main point of contact with regulatory agencies and managing the creation of CMC documentation for regulatory filings. Applicants should hold a bachelor’s degree in a life sciences or engineering field, along with a minimum of 10 years of regulatory CMC expertise within the biotech or pharmaceutical sector. Experience in cell therapy or viral vector production, coupled with a comprehensive understanding of FDA and ICH guidelines, is essential.
STEMHUNTER is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, gender identity, and gender expression), national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law. We comply with all applicable equal employment opportunity and affirmative action regulations.
