Director/Senior Director, Chemical Development

Full Time
Posted 2 months ago

Summary of Position

Arrivent Biopharma is looking for a highly motivated, entrepreneurial individual to lead Chemical Development for small molecules (including payload for Antibody Drug Conjugates) from pre-clinical to NDA, and post approval life cycle management.

Key Responsibilities

  • Lead CMC development with partners and CDMOs from process development (API, formulation, analytical method) to clinical and commercial material manufacturing (API and DP). Generate CMC strategy, timeline, and budget to advance clinical trials and product launch.
  • Lead preparation and review of CMC sections related to IND and NDA submissions. Attend meetings with FDA, EMEA and prepared responses to agency questions.
  • Serve as the subject matter expert for designing and optimizing chemical manufacturing processes taking consideration of speed, quality, cost, scalability, and reproducibility.
  • Support tech transfer, problem solving when development or manufacturing issues arise at CDMOs. Review development plan/reports, tech transfer documents and batch records.

Desired Skills and Experience

  • Experience in leading small molecule CMC team for clinical and commercial products.
  • Author/review CTD for NDA filings. Familiar with FDA, EMEA, and PMDA requirements. Representing CMC in meetings with regulatory agency.
  • Design and implement new chemical routes and processes suitable for scale-up. Ability to analyze and interpret complex chemistry problems and provide solutions.
  • Knowledge and experience in payload synthesis for Antibody Drug Conjugates) is desired.
  • Knowledge and experience in small molecule analytics or formulation development is a plus.
  • Strong communication and influencing skills.

Education Requirement

  • A PhD in Organic Chemistry, Chemical Engineering or related field with 7+ years of experience; BSc/MSc with relevant industrial experience to an equivalent level

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