Associate Director, Drug Product & Process Development; Molecules

Remote

Full time

R12455

The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for late‑stage drug product development programs, including process characterization, control strategy development, regulatory filings (IND amendments, NDA/MAA), and post‑approval lifecycle management (LCM). This role will serve as a key CMC contributor to cross‑functional program teams, ensuring robust, scalable, and regulatory‑compliant drug product processes from Phase 2/3 through commercialization and beyond.

• Lead late ‑
  stage
  drug product development activities (Phase 2/3 through commercial launch), including formulation optimization, process validation readiness, and robustness studies.
• Provide technical oversight for drug product manufacturing processes
  , including scale‑up, tech transfer, PPQ, and commercial manufacturing support.
• Ensure development strategies align with Quality by Design (
  QbD ) principles, with clearly defined CMAs, CPPs, and control strategies.
• Author and review technical development plans, process descriptions, development reports, and validation summaries.

• Serve as a CMC drug product lead for NDA (and/or MAA) filings
  , including preparation and review of Modules 2.3 and 3 sections related to drug product and manufacturing processes.
• Support Health Authority interactions (FDA, EMA, etc.), including information requests, deficiency responses, and commitment fulfillment
  .
• Ensure drug product development content is compliant with current regulatory expectations and global guidelines (e.g., ICH Q8–Q12).

• Lead and support post ‑
  approval
  LCM activities
  , including formulation changes, site transfers, process improvements, specification updates, and alternate sourcing.
• Assess change impact and support regulatory submissions (PAS, CBE‑30, annual reports, variations).
• Drive continuous improvement initiatives to enhance process robustness, manufacturability, and supply reliability.

• Act as a technical representative on cross ‑
  functional
  program teams (Regulatory, Quality, Manufacturing, Supply Chain, Clinical, and Commercial).
• Provide technical direction to CMOs/CDMOs
  , ensuring alignment with development strategy, timelines, and quality standards.
• Mentor and guide junior scientists and engineers; contribute to building organizational CMC capabilities.

• PhD in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or related discipline with 5+ years of relevant industry experience OR
• MS with 8+ years / BS with 10+ years of progressive experience in drug product/process development

• Demonstrated experience in late ‑
  stage
  drug product development (Phase 3 to commercial)
• Direct involvement in NDA (or equivalent) CMC submissions
  , including authorship and regulatory agency interactions
• Provenexpertisein drug product manufacturing processes
  , scale‑up, tech transfer, and validation
• Strong understanding of CMC regulatory requirements and global regulatory frameworks
• Hands‑on experience with LCM strategies and
  post ‑
  approval
  changes
• Excellent technical writing, communication, andcross‑functional collaboration skills

• Experience working with external manufacturing partners (CDMOs)
• Experience with aseptic, solid oral, or other relevant dosage forms (tailor as needed)
• Familiarity with commercial manufacturing and supply support
• Prior people leadership or matrix leadership experience

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in…