Director, Drug Substance

Scorpion Therapeutics; California (MO); On-site; USD 180,000 - 260,000; Full time

Job summary

Revolution Medicines in Redwood City, CA, seeks a senior Lead Process Research and Development scientist to drive design, optimization and scale-up of RAS(ON) inhibitors within the Drug Substance function. You will lead cross-functional teams to ensure robust processes and regulatory readiness.

The ideal candidate holds a PhD (or MSc with 10+ years) in organic chemistry or chemical engineering, with 10–15+ years in process R&D and hands-on GMP/QbD experience, plus strong leadership for tech

Qualifications

• PhD (or MSc with 10+ years) in organic chemistry or chemical engineering.
• 15+ years (MS) or 10+ years (PhD) industry experience in process R&D.
• Expertise in synthetic organic chemistry, GMP, ICH guidelines, and regulatory submissions.

Responsibilities

• Lead design, optimization and scale-up of drug-substance processes.
• Ensure regulatory compliance through QbD principles and DOE studies.
• Manage technology transfer to CDMOs and CRO/CDMO relationships.
• Author regulatory documentation and collaborate across analytical, pharmaceutical, and supply chain teams.

Skills

Regulatory submissions

GMP knowledge

QbD principles

DOE studies

CRO/CDMO mgmt

Leadership

Cross-functional

Education

PhD in Chemistry or Chemical Engineering

MSc in Chemistry or Chemical Engineering

Job description

Role

Lead process research and development within the Drug Substance function for Revolution Medicines' late-stage oncology pipeline, focusing on process design, optimization, and scale-up of RAS(ON) inhibitors.

Responsibilities

develop and optimize chemical processes for drug substances and intermediates, ensure regulatory compliance through QbD principles and DOE studies, manage technology transfer to CDMOs, oversee CRO/CDMO relationships, author regulatory documentation, and collaborate across analytical, pharmaceutical, and supply chain teams.

Requirements

PhD (or MSc with 10+ years) in organic chemistry or chemical engineering; 15+ years (MS) or 10+ years (PhD) industry experience in process R&D; expertise in synthetic organic chemistry, GMP, ICH guidelines, and regulatory submissions; proven project management with CROs/CDMOs; strong problem-solving, communication, and leadership skills.

High Value

experience with biologics manufacturing, regulatory filings (IND, IMPD, NDA), and working with CMC strategies in a clinical or commercial setting.

Work Setup

onsite in Redwood City, CA, with up to 15% travel for CRO/CDMO oversight.