Associate Director, Drug Substance Development

About This Role

This role will provide scientific and technical leadership for drug substance development projects within a global biopharma company, focusing on process design and development studies at various stages of the development life-cycle. The successful candidate will lead the cGMP manufacture of small molecule drug substances at CDMOs, ensuring adequate supply for clinical studies and regulatory compliance.

Responsibilities

• Lead the process development and cGMP manufacture of small molecule drug substances at CDMOs
• Ensure adequate supply of drug substance for clinical studies and other needs
• Oversee the development of robust and reliable manufacturing processes utilizing Quality by Design (QbD) principles
• Oversee the synthesis of chemical entities to support clinical and non-clinical studies
• Ensure that all DS processes are in line with all applicable regulations, policies, guidelines, and procedures
• Represent the drug substance team on cross-functional project teams as needed
• Work closely with other cross-functional CMC project team members to deliver on agreed project goals
• Author and/or review drug substance sections of regulatory dossiers and technical reports
• Support other Technical Operations functions to ensure a smooth transfer of technologies and products to manufacturing sites
• Plan, budget, execute and report on assigned projects

Requirements

• Over ten years of experience in drug substance development and manufacturing
• Demonstrated technical expertise in chemical process development and new product introduction
• Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought in experimental design
• Demonstrated troubleshooting and problem-solving skills
• Experience of CMC regulatory requirements for pharmaceutical products
• Proven project management skills for technical programs
• Excellent written and verbal communication skills

Qualifications

• Bachelor’s degree and Masters or PhD in Chemistry
• Over ten years of experience with broad experience across drug development and manufacturing technologies, specifically in chemical process development and drug substance.

Nice to Have

• Experience in managing and maintaining budgets
• Experience in defending processes, procedures, and investigation during FDA/EMA inspections
• Knowledge of formulation development and/or large molecule technologies

Benefits