Assoc Dir, Drug Product Development 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.

The Associate Director of Drug Product Development is responsible for providing scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs at various stages of the development life-cycle including preformulation, formulation and process development, technical transfer and validation. The Associate Director will oversee drug product aspects of development and manufacturing projects from pre-formulation and product feasibility through to clinical trial supply and technology transfer/commercialization. In addition, the Associate Director may provide leadership of cross-functional CMC development teams.

Essential Functions:

• Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with sufficient stability and robustness for clinical and/or commercial manufacturing.
• Responsible for specifying product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial); and in developing robust processes for pharmaceutical production.
• Directs projects and leads cross-functional teams (as required) with technical proficiency, scientific creativity, collaboration with others to achieve project goals on time and within budget.
• Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products.
• Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).
• Direct technical projects (internally and at CDMOs) including developing detailed technical work plans and managing performance of vendors.
• Work cooperatively with, or lead, internal and external teams as required.
• Author CMC sections of regulatory dossiers for products at all stages to enable acceptance by global regulators.
• Supports asset due diligence and new product introduction and integrations.
• Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations.

Required Knowledge, Skills, and Abilities:

• 10+ years’ experience in drug product development in the pharmaceutical industry required.
• Direct experience with formulation development, process development, technical transfer and/or process validation.
• Demonstrated technical proficiency, engineering, collaboration with others, and independent thought.
• Strong teamwork skills.
• Demonstrated troubleshooting and problem-solving skills including the use of designed experiments, statistical process control.
• Development/authorship of CMC regulatory filings for pharmaceutical products.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms preferred.
• Excellent written and verbal communication skills.
• Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
• Experience in intellectual property development desirable.
• Proven project management skills for technical programs.
• Flexibility to travel on company business when required.

Required/Preferred Education and Licenses:

• Advanced degree in Chemistry, Pharm. Sci., Engineering, or related field, or equivalent combination of education and work-related experience required.

Description of Physical Demands:

• Occasional mobility within office environment.
• Routinely sitting for extended periods of time.
• Constantly operating a computer, printer, telephone and other similar office machinery.

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.