If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharma.com and follow @JazzPharma on Twitter.
* As part of the MS&T group, the primary function of this role is accountable for leading and managing the global packaging technologist service including pack engineering (pack design, testing, validation), packaging equipment sourcing and qualification, serialization, brand protection and developing a broader global pack service and supply strategy to ensure the right capabilities, resources, and accountabilities across all line functions requiring packaging service support. improvements, process technical support including production troubleshooting and process optimisation activities, as well providing packing expertise into key Jazz projects.
* The role will lead primarily external packing activities with some support for internal packing activities at Jazz manufacturing.
* This role will provide oversight and expertise to the External Manufacturing Supply Team for packing activities being conducted by external contract manufacturing organisations (CMOs).
* This includes all Jazz manufacturing sites as well as support for external contract manufacturing organizations’ (CMOs).
Essential Functions
* Functional leadership of packaging projects for products being manufactured both internally and externally in CMOs. This may also include technical transfers between sites.
* For internal manufacture this includes designing the pack, selection of components, testing of the pack, sourcing and qualification of packaging equipment, approving artwork design, ensuring that relevant standards are met.
* For external manufacture at CMOs, this will include input into selection of the CMO, pack design, oversight of packaging process qualification activities.
* Ensuring that project management tools are used to deliver activities on time and in budget, and to ensure effective communication with key stakeholders and leadership teams. Build strong cross functional relationships internally and externally.
* Will attend Manufacturing Product Supply Team (MPST) meetings on an as needed basis to provide packaging updates, escalate issues, and to reach alignment on decisions.
* Look to continuously improve both efficiency and effectiveness of packaging processes and associated systems.
* Actively participate in relevant Jazz management forums to lead and shape performance of the packaging team.
* Develop, establish and maintain global packaging standards
* Develop the global packaging strategy for Jazz, including vendor selection for packaging materials/ services.
* Support investigations/ troubleshooting into quality, safety, and downtime issues in manufacturing areas relating to packaging, using RCA tools as appropriate. Responsible for actively managing/ supporting all Quality System items related to packaging e.g. deviation investigations, CAPAs, Change Controls.
* Work closely with Pharmaceutical Development for strategy and ensuring competency and capability is in place within the Global Packaging Technologist team for new dosage forms being established for pipeline products e.g. tablets/ capsules
* Develop team and individuals within the team in order to expand expertise, experience and core competencies to ensure the team keeps abreast of industry trends and continues to deliver in a fast changing and challenging environment.
* Coach and mentor colleagues and team members in packaging technology. Promote the capability within the organization.
* Support authoring/ review of container closure sections of regulatory CMC modules.
* Subject matter expert (SME) for packaging and serialization operations for Regulatory, Customer and Internal/ Corporate audits
* Where required, deputise for and sign off relevant documentation in place of Director, Manufacturing Science and Technology.
Required Knowledge, Skills, and Abilities
* Subject matter expert in pharmaceutical packaging with a minimum of 10 years’ experience in the field
* Experience at maintaining operational standards to FDA and MHRA regulatory requirements
* Excellent computer literacy
* Excellent communication skills, including written, presentational, formal report writing
* Experience in senior stakeholder management, and working in cross functional teams (internally and externally)
* Project management skills and experience of setting and managing performance to financial budget
* Experience in leading teams
Required Education and Licenses
* Professionally qualified / equivalent experience in relevant technical field
Preferred Education and Licenses
* Minimum 2:2 BSc honors’ degree (or equivalent qualification) in a scientific, engineering or other technical discipline
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, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .