API Lead

As API Lead you oversee development and manufacturing of APIs and related materials via external CMOs, guiding projects from early development to commercialization. You serve as the main technical bridge between internal teams and external partners, ensuring quality, timelines, risks, and costs stay aligned. You apply expertise in GMP, regulatory CMC, and chemistry to solve complex development and manufacturing challenges. You work with cross-functional experts to deliver compliant, scalable API manufacturing solutions and help shape regulatory submissions.

• Lead development and manufacturing of APIs, precursors, and key materials at external CMOs from early development to commercialization
• Serve as primary technical interface between internal teams, CMOs, suppliers, and external partners
• Define development strategies, deliverables, timelines, risks, and priorities; oversee process development, optimization, scale-up, tech transfer, and GMP manufacturing
• Assess, select, qualify, and onboard CMOs and suppliers based on capabilities, capacity, quality, cost, timelines, and risk; monitor performance
• Lead technical, quality, and manufacturing challenges including deviations, investigations, change controls, and impurity issues
• Define API starting material, characterization, and impurity-control strategies with regulatory justification in line with ICH guidelines
• Prepare and review CMC documentation for manufacturing activities and regulatory submissions
• Collaborate with Quality, Regulatory, Analytical Development, Manufacturing, Supply Chain, Sourcing, IP, Legal, and project teams to ensure compliant execution of GMP, regulatory, quality, and EHS requirements

• PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, or related field
• Experience in API or pharmaceutical process development including scale-up, technology transfer, or manufacturing
• Demonstrated experience managing CMOs or outsourced pharmaceutical development and manufacturing
• Strong knowledge of GMP requirements, pharmaceutical development, and regulatory CMC expectations
• Strong understanding of API characterization, analytical method development, impurity investigations, and impurity-control strategies
• Experience preparing or supporting CMC documentation for regulatory submissions and health-authority interactions
• Excellent written and verbal communication and stakeholder-management skills in cross-functional, multicultural environments
• Fluent in English (spoken and written)

• stakeholder management
• communication
• ability to influence decisions
• synthetic chemistry
• GMP knowledge
• regulatory CMC