Director of Formulation Development

Website Innocare

Main Responsibilities: 

  • Supervise and support formulation development team to develop, optimize, scale-up, and manufacture CTM in support of IND, early and late-stage clinical studies.
  • Work with pre-clinical and CMC teams to characterize candidate compounds through pre-formulation studies and to develop toxicological formulations and clinical formulations for IND submission and first-in-human trials.
  • Develop dissolution strategy to support formulation screening and optimization. Evaluate enabling technologies for commercial dosage forms.
  • Work with CMOs or commercial plants to assist gap analysis, risk assessment, tech transfer, process DOE, and optimization.
  • Coordinate with external collaborators including international pharmaceutical companies to co-develop formulations and overlook the projects’ progress.
  • Evaluate and manage CMOs to ensure timely delivery of CTMs with high quality.
  • Draft and review regulatory filing documents of IND and NDA for NMPA, FDA, EMA, and TGA, etc.
  • Prepare and participate in interactive technical meetings with external collaborators and official reviewers in CDE.
  • Collaborate with other functional groups in pharmaceutical development, regulatory affairs, and clinical supply operation and contractors.

 

Qualifications:

  • D in pharmaceutical science or related fields.
  • Over 5 years’ experience in formulation or drug product development. Overseas working experience in global pharmaceutical company is preferred.
  • Familiar with pharmaceutical industry regulations such as ICH, NMPA and FDA guidance, etc. IND and NDA experience for FDA or EMA are preferred.
  • Excellent leadership and management skills, including supervision and mentoring of teams. Good communication and positive interpersonal skills.

Fluency in English (oral, writing communication skills) and Mandarin preferred.

 

Contact:

Please submit your resume and CV to Abbie.Huang@Innocarepharma.com and mention that you saw this JD on the SAPA website. 

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