Director, Drug Product Development
About The Position
We are seeking an experienced and strategic Director of Drug Product Development to lead and oversee the development of drug product formulations for small molecules, from early clinical phases through commercialization. The ideal candidate will bring 10–15 years of progressive experience in pharmaceutical development, with a strong emphasis on oral solid dosage forms and parenteral formulations. This role requires expertise in managing external development and manufacturing partners (CDMOs/CMOs), experience with amorphous formulation development, and a proven track record in regulatory submissions and successful product launches.
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.
Nice To Haves
- Hands-on experience in formulation development, tech transfer and process validation.
- Familiarity with QbD principles and stage-appropriate CMC strategies.
- Global regulatory experience (EMA, PMDA, etc.).
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
