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2 jobs similar to Associate Director, Drug Substance (Process Chemistry)

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$200,000–$260,000/yr
Global

  • Lead drug product CMC strategy for small molecule programs from early to late stage.
  • Oversee formulation, process development, scale-up, technology transfer, and validation.
  • Manage CDMOs and external partners to ensure quality, timelines, and supply continuity.

Our partner is a biotechnology company focused on advancing small molecule drug product development. They operate in a fast-moving, highly outsourced environment with a collaborative, patient-focused culture.

US

  • Develop and validate SAS and R programs to produce CDISC-compliant datasets and TLFs for clinical studies.
  • Serve as lead programmer on late-phase studies and regulatory submissions, ensuring high-quality, audit-ready deliverables.
  • Collaborate with cross-functional teams and mentor junior programmers to support statistical programming standards.

Pulmovant is a clinical-stage biotechnology company developing treatments for pulmonary diseases, including its lead candidate mosliciguat for PH-ILD. As part of the Roivant family, it emphasizes collaboration and innovation in advancing its pipeline.