A clinical stage biotechnology company focused on creating novel therapies is looking to hire a highly motivated Director of Drug Product Development. This individual will be responsible for development activities leading to commercialization. The position will report to the Senior Director of Drug Product Development. This role will require cross-functional collaboration with internal and external stakeholders to ensure the execution of CMC activities.
Responsibilities
Advance new innovations to commercialization stage
Lead all formulation activities (preformulation, process development, scale-up, tech transfer) related to solid oral dosage and parental forms
Develop and integrate innovative strategies to streamline CMC processes
Travel to external partners as needed
Qualifications
Ph.D. or M.S. in Pharmaceutical Sciences, Pharmaceutics, chemistry, Chemical Engineering or related field
15+ years of experience in pharmaceutical/bio tech industry with proven leadership capabilities
Technical expertise across all stages of drug development and experience with small molecule formulation
Thorough understanding of GMP requirements and FDA, EMA regulatory filings
Team-player mentality and strong communication skills
