Senior Director, Formulation Development
$235,000–$330,000 year
On-siteWatertown, Massachusetts, United States
Job Summary
Lead early formulation development activities across small molecule programs, providing scientific direction on preformulation characterization, enabling formulation strategies, and drug product design from preclinical through early clinical stages. Apply deep expertise in preformulation, biopharmaceutics, and enabling technologies to support candidate progression decisions, driving innovation to address solubility and bioavailability challenges. Design and execute phase-appropriate strategies for toxicology studies and clinical programs while coordinating with external CROs and CDMOs to ensure scientific quality and timeline adherence. Contribute to establishing best practices, SOPs, and GMP-compliant regulatory strategies for drug product development. Partner closely with Research, DMPK, and CMC functions to advance programs efficiently through IND.
Required Qualifications
- Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or related discipline
- 15+ years of relevant pharmaceutical industry experience
- focus on early-stage formulation development
- Demonstrated scientific expertise in early-stage pharmaceutical development
- track record of advancing small molecule programs from discovery through IND and into clinical development
- Strong understanding of preformulation, biopharmaceutics, formulation development, and oral solid dose drug product manufacturing for small molecules
- Deep expertise in formulation approaches for poorly soluble compounds
- application of enabling technologies to improve bioavailability and product performance
- Proven track record of advancing small molecule programs through IND
- hands-on expertise in preformulation characterization
- hands-on expertise in enabling formulation development
- early clinical drug product design
- Strong knowledge of GMP requirements
- regulatory expectations
- evolving industry trends
- Experience coordinating with external CROs and CDMOs to deliver formulation development objectives
- Strong scientific communication skills
- ability to collaborate effectively with cross-functional teams and external partners
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