Director, Drug Product Development - Small Molecules & Launch

Latigo Biotherapeutics, Inc.; San Francisco (CA); Hybrid; USD 180,000 - 270,000; Full time

Job summary

Latigo Biotherapeutics, Inc. is seeking an experienced Associate Director/Director of Drug Product Development to lead formulation and process development for small-molecule programs from candidate selection through clinical development, regulatory submission, and launch readiness.

The role requires strong expertise in oral solid dosage forms and enabling technologies for poorly soluble compounds. Parenteral dosage form experience is a plus; collaboration with CDMOs/CMOs, regulatory teams, and

Qualifications

• Experience leading drug product activities for development programs.
• Strong skills in formulation and process optimization, scale-up, PPQ/validation, stability, and launch readiness.
• Familiarity with regulatory submissions (INDs/NDAs/MAAs) and health authority interactions.

Responsibilities

• Lead drug product development strategy and execution for small-molecule programs.
• Serve as the CMC lead on cross-functional program teams and communicate options, risks, and timelines.
• Plan formulation and process development, including selection, scale-up, PPQ, and stability activities.
• Lead or support technology transfer to CDMOs/CMOs and manage PPQ, CPV, and launch prep.
• Develop product and process control strategies, parasgested attributes and process parameters.
• Provide technical leadership for oral solid dosage forms; apply enabling formulation approaches for poorly soluble compounds.
• Ensure timely delivery of clinical, registration, and launch materials with QA oversight.
• Author and review drug product sections of regulatory submissions (Module 3.2.P).
• Support interactions with global health authorities and inspection readiness.
• Partner with multiple functions to execute integrated program plans.
• Select and manage external partners; define scope, deliverables, budgets, and governance.
• Provide mentorship and leadership; contribute to standards and knowledge management.

Skills

Oral solid dosage development

Parenteral formulation knowledge

Regulatory submissions (CMC)

Technology transfer

Project leadership

Quality by Design

Education

PhD or MS in Pharmaceutical Sciences

Job description

Latigo Biotherapeutics, Inc. is seeking an experienced Associate Director/Director of Drug Product Development to lead formulation and process development for small-molecule programs from candidate selection through clinical development, regulatory submission, and launch readiness.

The role requires strong expertise in oral solid dosage forms and enabling technologies for poorly soluble compounds. Parenteral dosage form experience is a plus; collaboration with CDMOs/CMOs, regulatory teams, and