Director, Advanced Small Molecule Drug Product Development

BioSpace; Brisbane (CA); On-site; USD 218,000 - 260,000; Full time

Job summary

Nurix Therapeutics, Inc. seeks a highly experienced Director of Pharmaceutical Development to lead small molecule drug product development, focusing on oral and topical dosage forms.

You will guide QbD-based formulation, process development, scale-up, and regulatory submissions while managing CDMOs and cross-functional teams. The role requires 12+ years in pharmaceutical development, strong leadership, and a track record with late-stage development and regulatory filings (INDs/NDAs/CTDs).

Qualifications

• Ph.D. in Pharmaceutical Sciences or related field preferred with 12+ years of industry experience.
• Deep experience in small molecule drug product development for oral/topical dosage forms.
• Proven track record with CMC regulatory submissions (INDs/NDAs/CTDs).

Responsibilities

• Lead formulation and process development for small molecule programs from early phase to launch.
• Oversee QbD-based development and define QTPP/CQAs for products.
• Manage scale-up, tech transfer, and ongoing process verification.
• Oversee regulatory submissions and responses; ensure GMP compliance.
• Manage external CDMOs and cross-functional teams; mentor junior staff.

Skills

QbD methodologies

CDMO management

Cross-functional leadership

Project management

Regulatory strategy

GMP knowledge

People development

Analyzing risk (FMEA)

Oral/topical dosage forms

Technical leadership

Education

Ph.D. in Pharmaceutical Sciences or related

Job description

Nurix Therapeutics, Inc. seeks a highly experienced Director of Pharmaceutical Development to lead small molecule drug product development, focusing on oral and topical dosage forms.

You will guide QbD-based formulation, process development, scale-up, and regulatory submissions while managing CDMOs and cross-functional teams. The role requires 12+ years in pharmaceutical development, strong leadership, and a track record with late-stage development and regulatory filings (INDs/NDAs/CTDs).