Senior Director, Small Molecule Formulation Development

EPM Scientific; New York (NY); On-site; USD 180,000 - 280,000; Full time

Job summary

EPM Scientific in New York City seeks a Senior Director/Director of Formulation Development to lead drug product development for small molecules from preclinical to commercialization. You will steer formulation strategies, oversee GMP manufacturing, and coordinate with external CDMOs and cross-functional teams.

The role requires deep expertise in oral solid dosage forms, regulatory submissions, and lifecycle management, with a proven history of guiding programs to IND/NDA readiness and

Qualifications

• Ph.D. or M.S. in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline.
• 12+ years (Director) or 15+ years (Senior Director) of experience in pharma/biotech.
• Significant experience leading formulation and drug product development for small molecule programs.
• Experience advancing compounds from preclinical or Phase I through late-stage development and commercialization.
• Deep understanding of oral solid dosage formulation development, manufacturing, scale-up, and commercialization.
• Experience managing external CDMOs and development partners.
• Proven track record supporting IND, NDA, and global regulatory submissions.

Responsibilities

• Lead formulation and drug product development strategies supporting small molecule programs from IND-enabling studies through registration and commercialization.
• Define phase-appropriate formulation approaches balancing clinical needs, manufacturability, regulatory expectations, and commercial considerations.
• Guide dosage form selection and product presentation strategies to support program objectives and lifecycle opportunities.
• Develop integrated development plans, budgets, timelines, and risk mitigation strategies for drug product activities.
• Provide strategic and technical leadership across preformulation, formulation development, process development, scale-up, technology transfer, and GMP manufacturing.
• Oversee development of oral solid dosage forms including tablets, capsules, IR, MR, and enabling formulations.
• Drive formulation approaches for compounds with solubility, bioavailability, stability, or manufacturability challenges.
• Establish and maintain robust control strategies and specifications aligned with regulatory expectations.
• Support process validation, registration batches, and commercial launch readiness.

Skills

Formulation development leadership

CDMO management

Regulatory submissions

Oral solid dosage experience

Cross-functional collaboration

Education

Ph.D./M.S. in Pharmaceutics or related field

Job description

EPM Scientific in New York City seeks a Senior Director/Director of Formulation Development to lead drug product development for small molecules from preclinical to commercialization. You will steer formulation strategies, oversee GMP manufacturing, and coordinate with external CDMOs and cross-functional teams.

The role requires deep expertise in oral solid dosage forms, regulatory submissions, and lifecycle management, with a proven history of guiding programs to IND/NDA readiness and