Associate Director, Drug Product & Process Development; Molecules

## Associate Director, Drug Product & Process Development (Small Molecules)
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Posted Todayjob requisition :
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.
** Key Responsibilities
**** Drug Product & Process Development
*** 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.
** Regulatory Filings & Health Authority Interactions
*** 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).
** Lifecycle Management (LCM)
*** 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.
** Cross**‐
** Functional Leadership
*** 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
** Required Experience & Skills
*** 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…