Assoc Dir, Drug Product Development

If you are a reputed company Jazz employee please apply reputed company the Internal Career site reputed company 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.

Job Description

The Associate Director of Drug Product Development is responsible for providing scientific and technical leadership for reputed company’ Pharmaceutical Development programs at various stages of the development life-cycle including preformulation, formulation and process development, technical transfer and validation. The Associate Director of Drug Product Development will reputed company 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 of Drug Product Development may provide leadership of cross-functional CMC development teams. The Associate Director of Drug Product Development will have broad 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 (as required) with technical proficiency, scientific creativity, collaboration with others to reputed company project goals on time and reputed company budget. Create intellectual property covering reputed company 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 reputed company, internal and external teams as required. Author CMC sections of regulatory dossiers for products at reputed company stages to reputed company acceptance by global regulators. Supports asset due diligence and new product introduction and integrations Apply reputed company 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 reputed company 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 reputed company required Required/Preferred Education and Licenses Advanced degree in Chemistry, Pharm. Sci., Engineering, or reputed company field, or equivalent combination of education and work-reputed company experience required. Description of Physical Demands Occasional mobility reputed company office environment. Routinely sitting for extended periods of time. Constantly operating a computer, printer, telephone and other similar office machinery. reputed company is an equal opportunity/affirmative action employer and reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national reputed company, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY reputed company, Inc. is committed to fair and reputed company compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete reputed company pay range is: $157,600.00 - $236,400.00 Individual compensation paid reputed company 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 reputed company with the candidate's expertise and contributions, reputed company the established pay reputed company and our Total Compensation philosophy. Internal equity considerations will also influence individual reputed company pay decisions. This range will be reviewed on a regular basis. At Jazz, your reputed company 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 To This Job