Reporting to the Head of Quality, the AD of Laboratory Services will provide scientific and analytical technical leadership to the Laboratory Services.
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.
- Lead the development of new analytical methods to meet business needs.
- Develop annual business plans and budgets for the Laboratory Services.
- Represent Laboratory Services on global project teams contributing to overall project plans.
- Provide input to development projects such that they can be executed effectively.
- 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.
- Lead analytical investigations to establish root cause for atypical, out-of-specification or out-of-trend results.
- 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.
- Conduct audits of third party contract testing service providers.
Required Knowledge, Skills, and Abilities
- 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.
Required/Preferred Education and Licenses
- Relevant degree in science discipline required
- Higher degree (MSc /Ph.D.) preferred but not essential depending on experience
For a confidential discussion and more information on the role, please contact Tina Egan