Company Overview
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for patients with serious diseases. Our diverse portfolio includes marketed medicines and novel product candidates in neuroscience and oncology.
About the Role
We are seeking an experienced Process Development Engineer to join our Technical Services Department within the Manufacturing, Science and Technology Group (MS&T). As a key member of our team, you will provide technical leadership to introduce new biologics products and processes, as well as improve existing ones.
Main Responsibilities
* Support technology transfer of processes into manufacturing for both internally and externally developed processes.
* Work cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
* Author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing.
* Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations.
* Evaluate existing processes and identify opportunities for improvement to advance efficiency, consistency, and competitiveness within the market.
* Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports.
* Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
Requirements
* Significant experience in pharmaceutical development and manufacturing with a strong background in both small and large molecule technologies.
* Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule.
* Proven project leadership roles in process validation, PPQ, and commercial manufacturing.
* Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required.
* Proven experience on cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies.
* Ability to deliver objectives on time in pressurized, fast-paced environments, while also meeting all compliance, quality, and cost targets.
* Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
* Good interpersonal, team, and collaborative skills are required.
* Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
* Strong understanding of Environmental, Health & Safety Requirements Strong understanding of Quality System Requirements Foster a culture of change, innovation and self-improvement to maximise achievement of overall site goals
Education and Qualifications
A Ph.D. (or Masters) degree in relevant field such as Chemistry, Pharmaceutical Science, Biotechnology, Chemical Engineering or related field and preferably with 10+ (15+) years in a pharmaceutical or biotechnology CMC/cGMP environment.
Benefits
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.
The successful candidate will also be eligible to participate in various benefits offerings, including medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.