Director, Small Molecule Formulation & Process Development

The International Society for Pharmaceutical Engineering, Inc.; California, Northern (MO, KY); Hybrid; USD 218,000 - 260,000; Full time

Benefits offered by this job

Bonus and equity

Job summary

Nurix Therapeutics, Inc. is seeking a Director of Pharmaceutical Development to lead small molecule drug product development, focusing on oral and topical dosage forms, from early development through commercial launch.

The role emphasizes QbD-driven formulation, cross-functional collaboration, and CDMO management, with on-site work in Brisbane, CA and about 25% travel. You will oversee scale-up, process transfer, regulatory submissions (INDs/NDAs/MAAs), and GMP compliance while mentoring a team

Qualifications

• Ph.D. in Pharmaceutical Sciences or related with 12+ years industry experience.
• Experience in small molecule drug product development for oral/topical dosage forms.
• Late-stage development experience (Phase 2b/3 and NDA/MAA) required.
• Authoring/reviewing CMC regulatory submissions (INDs, NDAs, CTDs).
• Direct CDMO management experience with vendor qualification and oversight.
• Travel ~25% domestically and internationally; able to gown for GMP environments.

Responsibilities

• Lead QbD-based formulation and process development for small molecule programs (oral/topical).
• Scale-up from lab to pilot and commercial scale; troubleshoot deviations and drive RCA.
• Drive late-stage development (Phase 2b/3) and regulatory submissions (INDs/NDAs/MAAs).
• Manage external CDMOs and cross-functional teams; mentor scientists and project staff.

Skills

Cross-functional leadership

Regulatory submissions

QbD methodologies

CDMO management

GMP knowledge

Project management

DoE

Strategic thinking

Communication

Mentoring

Education

Ph.D. in Pharmaceutical Sciences or closely related field

Job description

Nurix Therapeutics, Inc. is seeking a Director of Pharmaceutical Development to lead small molecule drug product development, focusing on oral and topical dosage forms, from early development through commercial launch.

The role emphasizes QbD-driven formulation, cross-functional collaboration, and CDMO management, with on-site work in Brisbane, CA and about 25% travel. You will oversee scale-up, process transfer, regulatory submissions (INDs/NDAs/MAAs), and GMP compliance while mentoring a team