Associate Director, Drug Product & Process Development – Small Molecules

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver technical and strategic guidance for late-stage drug product development initiatives.

• Oversee Phase 2/3 and commercial launch activities, focusing on formulation optimization, process validation readiness, and robustness studies.

• Provide technical supervision for manufacturing processes, scale-up, technology transfer, PPQ, and support for commercial manufacturing.

• Ensure that development strategies comply with Quality by Design principles along with established CMAs, CPPs, and control strategies.

• Draft and review technical development plans, process descriptions, development reports, and validation summaries.

• Act as the CMC drug product lead for NDA and/or MAA submissions, including Modules 2.3 and 3.

• Assist with interactions involving the FDA, EMA, and other Health Authorities, addressing information requests, deficiency responses, and fulfilling commitments.

• Lead and assist with post-approval lifecycle management tasks, which include formulation modifications, site transfers, process enhancements, specification revisions, and alternative sourcing.

• Evaluate change impacts and aid in regulatory submissions such as PAS, CBE-30, annual reports, and variations.

• Promote continuous improvement to boost process robustness, manufacturability, and supply reliability.

• Represent drug product technical development on cross-functional program teams.

• Offer technical guidance to CMOs/CDMOs.

• Mentor junior scientists and engineers while enhancing organizational CMC capabilities.

⛳️ Requirements

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

• Proven experience in late-stage drug product development ranging from Phase 3 to commercial stages.

• Direct participation in NDA or equivalent CMC submissions, including authorship and interactions with regulatory agencies.

• Proficiency in drug product manufacturing processes, scale-up, technology transfer, and validation.

• Strong knowledge of CMC regulatory requirements and global regulatory landscapes.

• Practical experience with lifecycle management strategies and post-approval modifications.

• Exceptional technical writing, communication, and cross-functional collaboration abilities.

• Experience with external manufacturing partners (CDMOs) is preferred.

• Familiarity with aseptic, solid oral, or other relevant dosage forms is preferred.

• Understanding of commercial manufacturing and supply support is preferred.

• Previous experience in people leadership or matrix leadership is preferred.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Opportunity for incentives.