Director, Drug Product Development – Small Molecule

Digitailor; San Francisco (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

Digitailor seeks an experienced Associate Director/Director, Drug Product Development to lead drug product development for small-molecule programs from candidate selection through clinical development, registration, and commercialization.

The role requires strong expertise in oral solid dosage forms and enabling formulation technologies, including amorphous solid dispersions, spray drying, and hot-melt extrusion. Travel ~20% and collaboration across global teams are expected.

Qualifications

• Lead drug product development for small-molecule programs from candidate selection through clinical development and launch.
• Provide technical leadership for formulation, process development, transfer, and regulatory readiness.

Responsibilities

• Oversee formulation and process development, scale-up, PPQ, and CPV activities.
• Lead technology transfer to CDMOs/CMOs and manage external partners.
• Develop control strategies including CQAs and CPPs and lifecycle monitoring.
• Prepare and review global CMC submissions and health authority interactions.
• Collaborate with multiple functional areas to align program plans and timelines.
• Mentor scientists and oversee risk assessment and mitigation strategies.

Skills

CMC Leadership

Oral Solid Dosage

Parenteral Formulations

Technology Transfer

Regulatory Submissions

Process Scale-Up

Education

Pharmaceutical Sciences/Related MS/PhD

Job description

Digitailor seeks an experienced Associate Director/Director, Drug Product Development to lead drug product development for small-molecule programs from candidate selection through clinical development, registration, and commercialization.

The role requires strong expertise in oral solid dosage forms and enabling formulation technologies, including amorphous solid dispersions, spray drying, and hot-melt extrusion. Travel ~20% and collaboration across global teams are expected.