Associate Director, Drug Product Development - Remote

EPM Scientific

South San Francisco (CA)

On-site

USD 180,000 - 220,000

Full time

7 days ago
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Benefits offered by this job

Fully remote
Long-term incentive opportunities
Remote work flexibility

Job summary

EPM Scientific is seeking an Associate Director of Drug Product Development in South San Francisco, CA to lead formulation and drug product development across multiple small molecule programs, advancing candidates toward registration and commercial readiness.

You will oversee process development, scale-up, technology transfer, and external partnerships, ensure GMP compliance, and collaborate with regulatory, QA, analytical, and supply chain teams.

Qualifications

  • PhD or MS with extensive pharmaceutical development experience.
  • Experience across late-stage and commercial readiness.
  • Strong knowledge of formulation development and scale-up.
  • Proven ability to manage outsourced development programs.

Responsibilities

  • Lead drug product development strategy for small molecule programs.
  • Direct formulation, process development, scale-up, and tech transfer.
  • Design phase-appropriate clinical formulations aligned with timelines.
  • Author and review CMC documentation and regulatory submissions content.
  • Manage external development and manufacturing partners (CDMOs).
  • Collaborate with cross-functional teams (analytical, regulatory, QA, supply).

Skills

Drug product dev
Process optimization
Tech transfer
CDMO management
Regulatory submissions
Leadership
Cross-functional collaboration
Project management

Education

PhD in Pharmaceutical Sciences
MS in related field

Job description

EPM Scientific is seeking an Associate Director of Drug Product Development in South San Francisco, CA to lead formulation and drug product development across multiple small molecule programs, advancing candidates toward registration and commercial readiness.

You will oversee process development, scale-up, technology transfer, and external partnerships, ensure GMP compliance, and collaborate with regulatory, QA, analytical, and supply chain teams.

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