Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for patients with serious diseases. This role reports to the Senior Director, Drug Substance Development and provides scientific and technical leadership for drug substance development projects across their life‑cycle.
Key responsibilities include:
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, reliable manufacturing processes using Quality by Design principles.
Oversee the synthesis of chemical entities to support clinical and non‑clinical studies.
Ensure processes comply with all applicable regulations, policies, guidelines, and procedures.
Represent the drug substance team on cross‑functional project teams as needed.
Work closely with CMC project team members to deliver on agreed project goals.
Contribute to functional continuous‑improvement initiatives.
Author and/or review drug substance sections of regulatory dossiers and technical reports.
Support other Technical Operations functions to ensure smooth transfer of technologies and products to manufacturing sites.
Communicate ideas and results clearly to technical and non‑technical audiences.
Plan, budget, execute, and report on assigned projects.
Develop knowledge of new pharmaceutical manufacturing processes and technologies and share best practices.
Required knowledge, skills, and abilities:
Strong record of achievement in drug substance development and manufacturing.
Over ten years of experience with broad exposure across drug development and manufacturing technologies, especially chemical process development.
Demonstrated technical expertise in chemical process development and new product introduction.
Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thinking in experimental design.
Demonstrated troubleshooting and problem‑solving skills.
Experience of CMC regulatory requirements for pharmaceutical products.
Demonstrated track record of training and coaching colleagues to improve overall team process knowledge.
Demonstrated track record of delivering positive results consistently.
Proven project management skills for technical programs.
Experience in managing and maintaining budgets.
Experience defending processes, procedures, and investigations during FDA/EMA inspections.
Capability to grasp complex technical issues and make sound decisions based on data.
Knowledge of formulation development and/or large molecule technologies would be advantageous.
Excellent written and verbal communication skills.
Required/Preferred Education and Licenses: Bachelor’s degree and Master’s or PhD in Chemistry.
Jazz Pharmaceuticals is an equal‑opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Eligible benefits include medical, dental, and vision insurance, retirement savings plan, and flexible paid vacation.
Compensation for US‑based candidates: $198,400.00 – $297,600.00 per year.
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