Category: Manufacturing | Country: Ireland | State: Roscommon | City: Athlone | Type: Regular Full Time Job ID: 4155
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
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.
- 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 interdepartmental projects
Required Knowledge, Skills, and Abilities
- 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 an 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
Required/Preferred Education and Licenses
- BSC in science discipline required
- MSC desireable
Jazz Pharmaceuticals is an Equal Opportunity Employer.