Director, Drug Product Development (Home Based / Remote)

If you are a current Jazz employee please apply via the Internal Career site. 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. Please visit www.jazzpharmaceuticals.com for more information. The 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 Director of Drug Product Development 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 Director of Drug Product Development will be expected to provide leadership of cross-functional CMC development teams. The Director of Drug Product Development will have extensive experience in pharmaceutical product development, demonstrated problem solving ability, module 3 authorship, development of robust manufacturing processes through designed experiments and data analysis, and excellent project management, teamwork and leadership skills. 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 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.
• Assist other department team members in providing guidance / mentoring / reviewing documents / data in support of product development (e.g. clinical protocols, PK study results).
• Enhance and improve ways of working in Drug Product development, utilising knowledge of industry best practice

Required Knowledge, Skills, And Abilities

• 10 – 15 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 track record in delivering achievements with meaningful impact in Pharmaceutical Development projects
• Demonstrated ability to lead cross-functional CMC Development teams
• Demonstrated troubleshooting and problem-solving skills including the use of designed experiments, statistical process control,
• Development/authorship of CMC regulatory filings for pharmaceutical products.
• Experience in defending processes, procedures and investigation during Regulatory Agency inspections desirable.
• Track record in generating intellectual property development.
• Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms.
• Excellent written and verbal communication skills, with demonstrated ability to communicate at executive leader level
• Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation.
• Proven project management skills for technical programs.
• Flexibility to travel on company business when required

Required/Preferred Education And Licenses

• Master’s degree, PhD, 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. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $198,400.00 - $297,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html. Apply tot his job Apply To this Job