Job Description
Our client is a fast-growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.
Our client has a modern manufacturing facility that also provides technical support to many products in development, clinical investigational medicinal products and commercial products manufactured in CMOs.
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 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 company 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 troubleshooting 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 the overall schedule, being the key point of contact.
- Lead analytical investigations to establish a 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 the broader team, advocate and implement initiatives in support of a continuous improvement philosophy.
- Management of controlled drugs within the laboratory (as required).
Person Spec
- Relevant degree in a science discipline
- Higher degree (MSc /Ph.D.) preferred but not essential depending on experience
- 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.
For further information on this Associate Director Analytical Services, Associate Midlands position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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