Associate Director, Drug Product & Process Development; Molecules

The Associate Director, Drug Product & Process Development, will provide technical and strategic leadership for early/late‑stage drug product development programs, including formulation design, process characterization, control strategy development, regulatory filings, and post‑approval lifecycle management (LCM), as needed. This role will serve as a key CMC contributor to cross‑functional program teams, ensuring robust, scalable, and regulatory‑compliant formulations and drug product processes from Phase 1/2 through Phase 3 and beyond.

Lead early/late‑stage drug product development activities (Phase 1/2 through Phase
3) for oral, injectable and/or complex dosage forms, including formulation design & optimisation, process validation readiness, and robustness studies.

Provide technical oversight for drug product manufacturing processes, including scale‑up, technical transfer, and 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 CMC/Drug Product Lead for early/late-phase regulatory filings, including preparation and review of 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).

Provide technical oversight at CDMOs for formulation design and manufacturing of phase‑appropriate and patient‑centric dosage forms.

Review development reports, batch records, and validation documentation from external partners.

Work with Quality and Supply Chain to support reliable clinical supplies through development.

Act as a technical representative and CMC/Drug Product Lead on cross‑functional program/CMC 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 early/late‑stage drug product development for small molecules.
• Direct involvement in regulatory CMC submissions, including authorship and regulatory agency interactions.
• Proven expertise in drug product manufacturing processes, scale‑up, technical 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.

• Demonstrated ability to drive integrated CMC/product development activities and connect the dots between cross‑functional CMC disciplines.
• Experience working with external manufacturing partners (CDMOs).
• Experience with sterile injectables, solid oral, and/or complex dosage forms.
• Familiarity with clinical manufacturing and supply support.
• Prior people leadership or matrix leadership experience.

• Ac…