Associate Director, Drug Product & Process Development (Small Molecules)

Key Responsibilities

• 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.

Qualifications

• Education: 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.
• Experience: 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 Proven expertise in 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, and cross-functional collaboration skills.

Preferred Qualifications

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