Senior Technical Analytical Specialist
An excellent opportunity has arisen for an experienced Senior Analytical Scientist/Specialist to join a leading global biopharmaceutical company at its established manufacturing operation in Sligo.
This is a particularly interesting opportunity for someone who enjoys the technical side of analytical science and wants to progress their career without necessarily moving into people management. This is an opportunity to move beyond routine analytical testing and become a senior technical expert within a highly sophisticated pharmaceutical manufacturing environment. The site is a small-molecule, high-potency manufacturing operation, producing high-potency Active Pharmaceutical Ingredients as well as potent oral solid-dose products such as tablets and capsules.
You'll have exposure to complex analytical work, high-potency API manufacturing, new laboratory infrastructure, method development and transfer, technical investigations and cross-functional projects.The company is a major global biopharmaceutical organisation with a substantial presence in Ireland, offering the opportunity to build your career within a highly regulated and technically advanced environment.
For someone who enjoys solving difficult analytical problems, troubleshooting and being the person others turn to for technical expertise, this could be an excellent next step.
The Role
As Senior Technical Analytical Specialist, you will be one of the key technical experts supporting analytical laboratory operations on site.
This is not simply a routine QC testing position. You will provide technical leadership across analytical methods, laboratory equipment, compliance, investigations and method validation and transfer.
You will work closely with QC, Quality, MS&T, R&D, Process, EHS and Laboratory Management, acting as a technical resource for analysts and wider project teams.
Responsibilities
- Providing technical expertise across routine, non-routine and advanced analytical testing.
- Leading troubleshooting and technical investigations relating to analytical methods, equipment and results.
- Supporting analytical method development, validation, transfer and implementation.
- Supporting the transfer of validated analytical methods into QC.
- Acting as a technical SME for laboratory equipment, systems and analytical activities.
- Supporting laboratory equipment selection, qualification, maintenance and optimisation.
- Writing and maintaining SOPs, protocols and technical documentation.
- Supporting deviations, CAPAs, audits and regulatory inspections.
- Ensuring analytical activities comply with cGMP, GLP, ICH and FDA/HPRA requirements.
- Supporting the development and optimisation of new laboratory infrastructure and systems.
- Mentoring and coaching analysts and project teams from a technical perspective.
Requirements
- Degree or diploma degree in science.
- Approximately 5 years' experience within pharmaceutical analytical science, QC, Technical Operations or a similar environment.
- Strong hands-on experience with analytical techniques such as HPLC, GC, KF, dissolution, MS and/or XRD.
- Strong experience in method development, validation, transfer and troubleshooting.
- Good knowledge of cGMP and pharmaceutical regulatory requirements.
- Experience supporting technical investigations, deviations or CAPAs.
- Some previous technical leadership, mentoring or team-lead experience.
If you're an experienced analytical professional who wants to take the next step technically without necessarily moving into people management, I'd be very interested in speaking with you.
