Associate Director/Director of Pharmaceutical Formulation Development
Department: CMC
Job Title: Associate Director/Director of Pharmaceutical Formulation Development
Report to: Head of CMC
Location: US
MAIN REPONSIBILITIES:
- Design, develop and optimize phase-appropriate drug product formulation development, especially in oral dosage forms
- Screen and select suitable CMDOs/CMOs; lead and manage outsourcing activities (formulation/product development and manufacturing) at the CDMO/CMO sites, in alignment with program goals
- Act as key product SME for the successful execution of technology transfer of drug product processes to manufacturing site(s), providing technical input/insights to the CDMOs/CMOs
- Draft, review and approve specifications, batch records and other critical development/GMP documents
- Draft, review and complete drug product sections of regulatory documents (IND, IMPD, NDA, DSUR, etc.) in a timely manner
- Help recruit and assemble the US CMC team
- Make, report, and communicate objectives, budget, strategy, progress, and timelines to the senior management team
- Contribute to patent applications, manuscript publications, and conference presentations
- Lead by example as a role model within our global CMC team and the organization a passionate commitment to developing high-quality drug products to help improve patients’ lives
QUALIFICATIONS:
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related areas with at least 8 years of biotech/pharmaceutical industry experience - OR - M.Sc. in the same field with at least 12 years of biotech/pharmaceutical industry experience
- Excellent understanding of the fundamentals/phase-appropriate formulation and manufacturing process development along with overall pharmaceutical product development process
- Expertise in development of immediate release oral solid dosage forms (capsules, tablets)
- Knowledge of current Good Manufacturing Practices (cGMP) and experience in pharmaceutical development of new chemical entities (NCE) under cGMP
- Ability to author/review technical reports to support regulatory filings (IND, IMPD, DSUR, NDA, etc.)
- Excellent written and verbal communication skills
- Strong interpersonal skills and ability to effectively communicate and collaborate colleagues within our internal CMC team and in other functional areas (drug supply, clinical, RA, etc.), and external CMOs/CDMOs
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team
- Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a fast-paced environment
- Bilingual in Chinese and English
