Athlone, County Westmeath, Ireland
This role will supplement and add to the existing technical support on site Provide technical support for existing manufacturing processes, in addition to development, commercialization, technology transfer of new processes into the operations/manufacturing environment Reporting into the head of Operations the role will provide scientific and technical leadership for drug product manufacturing on site as well as supporting external sites on an as needed basis
This position is responsible for providing strong scientific leadership for all aspects of technology transfer, process scale-up, process monitoring, and process troubleshooting to, drug product and finished product manufacturing activities on site (and as needed offsite). This responsibility includes all process validation activities Manufacturing process Scale up development including life cycle management projects Qualify and perform experiments in small scale models designed to further understand and improve the manufacturing process Master documentation for standard batch. Establish & update technical documentation such as: •MBR •FMEA •Process Flow Diagrams •Control Plans •Support operations with continuous improvements •Continuous Process Validation (CPV) Owns the process knowledge of the assigned product(s) throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters •New technology & Equipment introduction responsible for performing technical feasibility trials related to process improvement and implementation of new manufacturing technologies •Trouble shooting process and equipment issue technical input to significant issues/ deviations etc •Support continuous improvement in the manufacturing and development of products. •Liaise with global Process Development & Manufacturing Sciences group to facilitate transfer of technical knowledge. •Keep up to date with regulatory requirements •Liaise with Quality (APQR etc) to support the Annual Product Quality Report (PQR) by completing Data analysis, process monitoring & evaluation, etc. •Owner of technical services plans/ methods/ standards (Operations team will be responsible for execution to these standards/processes) •Maintenance Management •Calibration Management •Clean utility systems & strategies •P&ID maintenance •Provide support as appropriate to New Product and Technology Introduction team •Technical lead on interface with regulatory inspections
Required Knowledge, Skills, and Abilities •Minimum 8 years industry experience including manufacturing, process support, process troubleshooting, experience of in house and external manufacturing environments, design of experiments, process validation writing and execution. •Min 5 years’ experience in lead SME role in regulatory audits •Strong Organisational skills – in particular for knowledge management •Training and experience in problem solving skills e.g. 5 whys, fishbone diagram. •Project management an advantage •High level of competence with MS Word/Excel/Power point •Strong communicator •Broad knowledge in pharma 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 in area of expertise. •Recognize areas for improvement, and use initiative to implement change programs in support of progress. •Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment. •Ability to deliver objectives on time, every time, while meeting all compliance and cost targets. •Ability to generate documentation which is of a high standard. •Posses good organizational skills and attention to detail. •Posses good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally. •Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines. Required/Preferred Education and Licenses •Relevant Science /Engineering •MSc / PhD desirable
Athlone, County Westmeath, Ireland
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