Director of Drug Substance Development

About the role

The company, an innovative biotech firm, is looking for a Director of Drug Substance to lead the development and manufacturing of small‑molecule drug substances from late‑stage clinical through commercial launch.

Key responsibilities

• Lead and manage drug substance development and manufacturing with external CDMOs and partners.
• Define and execute validation strategies for late‑stage and commercial production.
• Ensure timely supply of clinical and commercial drug substance.
• Support global regulatory submissions (EU, US, APAC) and contribute to CMC plans.
• Prepare and evaluate RFPs, technical proposals, timelines and budgets.
• Oversee external manufacturing performance through regular reviews.
• Collaborate with Supply Chain, QA, Regulatory CMC and product teams.
• Author development reports, technical documentation and drive process improvements.
• Monitor project budgets, financial commitments and forecasting.

Required profile

• MSc or PhD in Organic Chemistry or related discipline.
• Minimum 10 years of experience in pharmaceutical or biotech industry.
• Extensive experience in small‑molecule drug substance development across the full product lifecycle.
• Proven track record in late‑stage clinical development, process validation and commercial manufacturing.
• Strong knowledge of GMP, Quality Risk Management and Quality by Design.
• Experience managing CDMOs and external manufacturing networks.

Required skills

• Small‑molecule drug substance development
• Process validation
• GMP manufacturing
• Quality Risk Management
• Quality by Design
• Regulatory submissions (EU, US, APAC)
• CDMO management