Jazz Pharmaceuticals Hiring for Laboratory Chemist Job at Athlone Full Time

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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Position Profile:

Brief Description:

Jazz Pharmaceuticals is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families by developing life-changing medicines for people with serious diseases. The Jazz Pharmaceuticals Athlone manufacturing and Development facility is an integrated pharmaceutical operation encompassing drug product manufacturing and packaging. The site was built and licensed in 2016 and currently manufactures two commercial products. The site also provides technical support to many products in development, clinical investigational medicinal products and commercial products manufactured in CMOs. The site is extending the scope to further support multiple commercial products, clinical supplies as well as other manufacturing operations completed externally.

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

• Apply technical expertise to method development, execution and troubleshooting of analytical techniques (GC, IC, HPLC, Dissolution, Spectroscopic techniques). Expertise in GC method optimisation/ troubleshooting would be advantageous

• Execute testing and certification/ disposition required for artwork, components, raw materials, finished product and stability testing to meet business goals ensuring right first time KPIs are achieved.

• Execute testing and certification/ disposition required for artwork, components, raw materials, finished product and stability testing to meet business goals ensuring right first time KPIs are achieved.

• 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.

• 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 including participation in complex investigations.

• Liaise with external suppliers/vendors in relation to laboratory requirements.

• Point of Contact for the Laboratory Services on inter departmental projects

Regular Analysis of data in order to extract decision making information in support of increasing efficiencies at all levels.

Identify and execute on continuous improvement / operational excellence opportunities as they apply to Laboratory Services.

• 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 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).

• 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.