Associate Director/Director of Pharmaceutical Formulation Development

  • Full Time
  • US

Website AnHeart Therapeutics

Department: CMC

Job Title: Associate Director/Director of Pharmaceutical Formulation Development Report to: Head of CMC

Location: US


  •  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




  • 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 the 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 with 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 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



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