- Provide SME support for a variety of investigational product development plans and efforts and provide knowledgeable regulatory compliance information relating to GMP, GLP, and GCP
- Provide commercial sector manufacturing perspective to Principal Investigators, advanced development Product Managers and others as they seek compliance with FDA rules and regulations
- Consult on the developmental-appropriate scientific and documentation requirements for compliance of facilities/laboratories and associated assays and processes from the sponsor’s perspective
- Interact frequently with RA Scientists, Product Managers, Clinical Affairs, Branch Chiefs, Laboratory Directors, Laboratory Technicians, and Quality Assurance representatives
- Develop and assist with laboratory and manufacturing compliance activities and related documentation to include those related to: product-related assays, product testing, accountability, manufacturing, laboratory, data systems and equipment
- Facilitate efficient development of the product while ensuring compliance
- Provide consulting services on product development strategy as it pertains to the extent of compliance needed as a function of the appropriate stage of product development
- Share manufacturing and testing related regulatory compliance information with appropriate individuals, teams, and forums to reduce and/or prevent critical errors that may inhibit the development of products.
SKILLS AND EXPERIENCE:
- At least 20years of experience in research, manufacturing, non-clinical studies and FDA licensure of investigational products
- Specialized experience in (1) research protocol development and review, (2) assay development and validation, (3) regulatory compliance for clinical and non-clinical studies, and (3) auditing the performance of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs)
MINIMUM EDUCATION: Minimum of a Ph.D. or equivalent doctoral degree that included major study in an academic field related to the health sciences or allied sciences appropriate to the work of the position.