Associate Director, Drug Substance Development (Home Based / Remote) 12 Month FTC in London

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

Brief Description:

Reporting into the Senior Director, Drug Substance Development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the development life-cycle. Success requires application of scientific and/or engineering principles and creativity to process design and development studies, and translation into commercially feasible, reliable, and robust processes. Experience of the critical interface attributes between drug substance and drug product will be especially relevant. Activities will be performed primarily with external contract development and manufacturing organisations (CDMOs). Other responsibilities will include cross-functional team leadership and/or membership, authoring technical reports and CMC sections of regulatory dossiers, and participation in department or functional initiatives. The role will involve significant cross functional collaboration with other functions including Quality, CMC Regulatory, Manufacturing, and New Product & Technology Integration working towards agile new product introduction and ensuring all processes are understood, robust, efficient and in control. The role is both project and operations orientated. It shall require an ability to drive and deliver multiple projects concurrently.

Essential Functions/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.
• Actively contribute to functional area continuous improvement initiatives.
• Author and/or review drug substance sections of regulatory dossiers and technical reports.
• Support other Technical Operations functions to ensure a smooth operation.