Associate Director / Director, Drug Product

Looking for an Associate Director / Director, Drug Product Development to provide scientific and strategic leadership for the development of robust, patient-ready drug products across the product lifecycle. This role is accountable for defining drug product strategies that address formulation, delivery, manufacturability, and regulatory readiness from early clinical development through commercialization.

The successful candidate will act as a senior technical authority for drug product decisions, partnering closely with CMC, Regulatory, Quality, Clinical, and external manufacturing partners to ensure successful and compliant product development.

Drug Product Strategy & Scientific Leadership

• Define and own the drug product development strategy for one or more programs, aligned with clinical and commercial objectives.
• Lead decision-making around dosage form selection, formulation approach, and delivery technologies.
• Provide expert oversight of enabling formulation strategies to address solubility, stability, bioavailability, and patient use considerations.
• Serve as the senior scientific escalation point for drug product-related risks and trade-offs

Formulation & Development Oversight

• Oversee development of solid oral, parenteral, or specialty dosage forms depending on company pipeline.
• Guide development of robust, scalable, and patient-centric formulations suitable for clinical and commercial manufacturing.
• Ensure alignment between formulation development, analytical strategy, and control strategy.

Scale-Up, Tech Transfer & Manufacturing Readiness

• Lead or oversee drug product scale-up and technology transfer to internal GMP facilities or external CDMOs.
• Ensure manufacturing readiness, including process descriptions, batch records, and control strategies.
• Act as the senior technical lead during GMP manufacturing campaigns, deviations, and investigations related to drug product.

CMC & Regulatory Leadership

• Provide senior scientific input into CMC strategies for global regulatory submissions (IND/IMPD/CTA, NDA/MAA).
• Review and approve drug product sections of Module 3, including formulation, manufacturing, and control strategies.
• Support health authority interactions, inspections, and responses related to drug product development.

Cross-Functional & External Engagement

• Partner closely with Process Development, Analytical Development, MSAT, Quality, Regulatory, Supply Chain, and Clinical teams.
• Act as primary scientific interface for external formulation partners and CDMOs.
• Drive risk-based development, lifecycle management, and continuous improvement initiatives.

Required Qualifications

• PhD (preferred) or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline.
• 8–12+ years of experience in drug product development within pharma, biotech, or CDMO environments.
• Proven track record delivering clinical and/or commercial drug products.
• Strong experience with formulation development, scale-up, and tech transfer.
• Deep understanding of cGMP, ICH guidelines, and global regulatory CMC expectations.
• Demonstrated leadership experience and strong cross-functional influence.