Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
This is a key role in the achievement of Jazz business objectives for the Jazz Athlone Development and Manufacturing facility. The Laboratory Chemist will be responsible for analytical stability, raw materials, in-process and finished product testing ensuring efficient and compliant day to day operations. The Laboratory Chemist will also be expected to participate in the transfer and validation of in-house methods The balance between routine QC testing and analytical development will and can change depending on priorities and the successful incumbent will need to adjust between both seamlessly.
The role is central to the Athlone Laboratory Services support of broad organisational objectives and development project activities.Essential Functions
Required Knowledge, Skills, and Abilities
- Participate in transfer and validation of in-house methods and verification of compendial methods to ensure the overall project schedule timelines are met.
- Implementation and maintenance of laboratory specific SOPs and test procedures.
- Upkeep of calibration and qualification programme for laboratory equipment.
- Input to weekly work plans for smooth operation of the laboratory.
- Execution and review of stability, raw materials, in-process and finished product work ensuring right first time KPI's are achieved.
- Trending of stability, raw materials, in-process, finished product results including participation in out of specification/ out of trend investigations.
- Assistance in the management of contract testing laboratories.
- Monitoring, evaluating and resolving issues related to day-to-day activities of operations in coordination with Quality and other site functions to ensure performance to schedule.
- Ensuring that all Quality Systems within the department are adhered to on a daily basis.
- Trouble-shooting within the Laboratory Services Department and providing technical assistance / support to other Departments as required.
- Liaise with external suppliers/vendors in relation to laboratory requirements.
- Point of Contact for the Laboratory Services on inter departmental projects
- Organising the periodic calibration and qualification programme for laboratory equipment.
- Monitor, evaluate and resolve issues related to day-to-day activities in coordination with Quality and other site functions to assure performance to schedule.
- Management of controlled drugs within the laboratory (as required).
Required/Preferred Education and Licenses
- Minimum of 3 years experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
- Possess fundamental scientific thought process/ problem solving abilities and ability to follow up with corrective actions
- Demonstrated technical expertise in multiple analytical techniques (GC, IC, HPLC, dissolution, spectroscopic techniques). Ideally considered a SME in many of the above mentioned techniques.
- Experience with method validation and method transfer and associated troubleshooting an advantage
- Recognize areas for improvement, and use initiative to implement change programs in support of progress
- Good knowledge of quality systems, FDA and EU regulations and ICH guidelines as they relate to Quality Control.
- Highly flexible, works well in a team and has necessary skills to organise, communicate, influence and lead.
- Experience of working in a best practice operational excellence environment, preferably with implementation experience (e.g. lean or six sigma techniques).
- Demonstrated capability in establishing collaborative working relationships at all levels
- Ability to deliver objectives on time, every time, while meeting all compliance and cost targets
- BSC in science discipline required
- MSC desireable
Jazz Pharmaceuticals is an Equal Opportunity Employer.