This is a key role in the achievement of Jazz business objectives for the Jazz Athlone Development and Manufacturing facility. The Laboratory Services Lead Chemist is primarily responsible for successfully executing analytical method development and optimisation in the Laboratory in support of early phase and late phase development projects. They will act as the analytical lead on projects across sites and functions within Jazz.
They will additionally be a key member of the Quality team responsible for analytical stability, raw materials, in-process and finished product testing ensuring efficient and compliant day to day operations. 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.
- Apply technical expertise to method development, execution and troubleshooting of analytical techniques (GC, IC, HPLC, Dissolution, Spectroscopic techniques). Laboratory SME for some or all of these techniques.
- Perform analytical investigations applying best practices for analytical problem solving to support formulation development activities.
- Develop new analytical methods to meet business needs. Assess opportunities to optimise / troubleshoot and improve current laboratory methods keeping abreast of current technologies.
- Execute testing and certification/ disposition required for artwork, components, raw materials, finished product and stability testing to meet business goals.
- Apply skills to solve complex analytical problems.
- Prepare CMC analytical sections for MAA applications.
- Lead projects within the Laboratory Services group with minimal supervision and take full accountability for project success.
- Represent Laboratory Services and Athlone on global project teams contributing to overall project plans.
- Provide input to development projects such that they can be executed effectively and in a compliant fashion. Provide analytical support for Jazz development projects as required.
- Make strategic proposals for ways to develop the Laboratory Services group (in terms of equipment and resources) to ensure it is optimally placed to offer solutions to the wider organisation.
- Independent trouble-shooting within the Laboratory Services Department providing capability in problem solving in a consistent/ logical manner.
- Transfer/validate in-house methods and verification of compendial methods to ensure overall project schedule timelines are met.
- Work with Development, Engineering and other functions to ensure a smooth transfer of technologies and products from Development to commercial manufacturing.
- Manage contract testing laboratories and sub-projects ensuring cost effective service as well as adherence to overall schedule, being the key point of contact.
- Lead analytical investigations to establish root cause for atypical, out-of-specification or out-of-trend results. Participate on cross functional teams for investigations and deviation support.
- Plan and implement operational systems to conduct laboratory testing in such a fashion as to control and reduce testing lead times and cost and improve other key indicators (such as reliability, flexibility, quality).
- 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.
- Laboratory Services signature authority for critical documents.
- Organising the periodic calibration and qualification programme for laboratory equipment.
- Conduct audits of third party contract testing service providers.
- Monitor, evaluate and resolve issues related to day-to-day activities in coordination with Quality and other site functions to assure performance to schedule.
- In close collaboration with broader team, advocate and implement initiatives in support of a continuous improvement philosophy.
- Management of controlled drugs within the laboratory (as required).
Required Knowledge, Skills, and Abilities
- Demonstrated technical expertise in multiple analytical techniques (GC, IC, HPLC, dissolution, spectroscopic techniques) and considered an SME in some or all of these techniques.
- Extensive experience in developing new analytical methods for drug product / drug substance analysis.
- Experience with method validation and method transfer and associated troubleshooting required.
- Possess fundamental scientific thought processes and demonstrated ability of overcoming analytical problems.
- Ability to think strategically and be a ‘go-to’ expert across the business for analytical development.
- 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).
- Experience with microbiological testing or working in a sterile manufacturing environment desirable.
- Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority
- Ability to deliver objectives on time, every time, while meeting all compliance and cost targets
Required/Preferred Education and Licenses
- BSc/MSc in science discipline required
Description of Physical Demands
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer.