Director, Drug Product Development

Role Overview

• Provide scientific and strategic leadership in the development of drug product formulations for small molecules, ensuring alignment with program goals and regulatory expectations.
• Lead CDMOs/CROs in conduct of pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing for small molecule drug products.
• Oversee the development and manufacturing of oral solid dosage forms (e.g., tablets, capsules); experience with parenteral dosage forms is highly desirable.
• Lead efforts in amorphous formulation development, including solid dispersions, spray drying, and hot-melt extrusion, to enhance solubility and bioavailability of poorly soluble compounds.
• Manage and coordinate activities with external partners, including CDMOs and CMOs, to ensure timely and compliant execution of development, tech transfer, scale-up, and manufacturing campaigns.
• Develop and implement CMC strategies for drug product development across all phases of development, from pre-IND to NDA/MAA.
• Lead cross-functional teams and collaborate closely with internal departments (e.g., Drug Substance, Analytical, Quality, Regulatory, Clinical, Project Management) to support program objectives.
• Author, review, and approve relevant sections of regulatory filings (IND, IMPD, NDA, MAA), including quality modules and responses to agency queries.
• Support technology transfer, process validation, and preparation for commercial manufacturing.
• Supervise and mentor subordinates.
• Maintain a strong knowledge of industry trends, emerging technologies, and evolving regulatory requirements in pharmaceutical development.

Requirements

• D. or M.S. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline with commensurate experience.
• 10–15 years of experience in drug product development for small molecule new chemical entities, with a successful track record from early-phase through commercialization.
• Expertise in oral solid dosage forms is required; experience with parenteral formulations is preferred.
• Hands-on experience with amorphous formulations, including enabling technologies to address low solubility, is highly desirable.
• Demonstrated success in managing external vendors (CDMOs/CMOs) and leading cross-functional teams.
• Extensive experience with regulatory filings including IND, NDA, and other global regulatory submissions.
• Strong leadership, organizational, and communication skills.
• Ability to operate effectively in a fast-paced, collaborative, and dynamic environment.
• Willingness to travel approximately 20% of the time, including domestic and international trips to partner sites and manufacturing facilities.