Jazz Athlone is a small integrated pharmaceutical operation. The site was built and licensed in 2016. The site currently manufactures a single commercial product. The site also provides technical support to many products in development, clinical investigational medicinal products and commercial products manufactured in CMOs.
The site is in a transition phase, whereby it will manufacture multiple commercial products, clinical supplies as well support other manufacturing operations completed externally. The Laboratory Services function on site currently offers many supports in terms of stability studies and as an alternate release testing site for final finished product.
This role will supplement and add to the existing technical support on site. The role will oversee a pharmaceutical quality control and stability testing laboratory, in addition to development of new analytical methods for an expanding product portfolio, supporting analytical research and development, optimising and improving methods, and providing analytical troubleshooting assistance.
The role is central to the Athlone Laboratory Services support of broad organisational objectives and development project activities.
Reporting to the Head of Quality, the role will provide scientific and analytical technical leadership to the Laboratory Services group on site, as well as supporting external stakeholders on an as needed basis. Leading up the site Laboratory Services group ensuring the following:
•Execute testing and certification / disposition required for artwork, components, raw materials, finished product and stability testing to meet business goals
•Apply technical expertise to lead method development, execution and troubleshooting of analytical techniques (GC, IC, HPLC, wet chemistry)
•Lead the development of new analytical methods to meet business needs. Assess opportunities to optimise / troubleshoot and improve current laboratory methods
•Lead projects within the Laboratory Services group with minimal supervision and take full accountability for project success
•Develop annual business plans and budgets for the Laboratory Services group to ensure adequate resourcing to meet ongoing business priorities
•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 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).
•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).
•Minimum 8-10 years' industry experience in a variety of Pharmaceutical Analytical Testing and Development Laboratories, with at least 3-5 years' management experience.
•A successful track record of achieving success in a management or supervisory role in a commercial QC group within a pharmaceutical company.
•Demonstrated experience in lead SME role in regulatory audits.
•Demonstrated technical expertise in multiple analytical techniques (GC, IC, HPLC, wet chemistry) and considered an SME in 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.
•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).
•Broad knowledge in pharmaceutical technologies and dosage forms (small molecule Drug Product development and manufacturing, Low Bioburden manufacturing and complex liposomal product are all beneficial).
•Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority.
•Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business.
•Recognize areas for improvement, and use initiative to implement change programs in support of progress
•Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
Required/Preferred Education and Licenses
•Relevant degree in science discipline required
•Higher degree (MSc / PhD) preferred but not essential depending on experience