Director, Drug Product Development — Oral Solids Expert

Latigo Bio; San Francisco (CA); Vor Ort; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

Latigo Bio is seeking an experienced Associate Director/Director of Drug Product Development to lead small-molecule programs from candidate selection through clinical development and launch readiness.

The role emphasizes expertise in oral solid dosages, enabling formulations, and technology transfer to CDMOs/CMOs, with strong cross-functional collaboration within a growing biotech environment.

Qualifikationen

• Lead drug product development for small-molecule programs.
• Experience with formulation and process development and scale-up.
• Authoring/review of regulatory drug product sections (Module 3.2.P).
• Manage CDMOs/CMOs and external partners.
• Strong knowledge of cGMP and ICH quality guidance.

Aufgaben

• Lead drug product development strategy and execution across programs.
• Serve as CMC lead on cross-functional teams and communicate options and risks.
• Plan formulation and process development, scale-up, and registration stability.
• Lead technology transfer to CDMOs/CMOs and PPQ/CPV activities.
• Develop control strategies and lifecycle monitoring for product quality.
• Provide guidance for oral solids and support parenteral forms when applicable.
• Oversee manufacturing, packaging, stability, investigations, deviations, and change controls.
• Contribute to INDs,** NDAs, MAAs, and Module 3.2.P content.

Kenntnisse

Oral solid dosage

Parenteral dosage forms (desirable)

amorphous solid dispersions

Process scale-up

Technology transfer

Clinical/registration supply

Quality by Design

cGMP knowledge

Regulatory submissions (Module 3.2.P)

Cross-functional leadership

Strong communication

Ausbildung

Ph.D. or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering

Jobbeschreibung

Latigo Bio is seeking an experienced Associate Director/Director of Drug Product Development to lead small-molecule programs from candidate selection through clinical development and launch readiness.

The role emphasizes expertise in oral solid dosages, enabling formulations, and technology transfer to CDMOs/CMOs, with strong cross-functional collaboration within a growing biotech environment.