Scientist, Chemistry Full-time NEW

Scientist/In Process Lab Co-ordinator

A fantastic opportunity has arisen for a Scientist/In Process Lab Co-ordinator.

Our In-Process testing team performs critical, real-time analysis across solvent recovery, bulk solvent tankers, spray-drier operations, API/intermediate and drug-product cleaning, environmental and utilities monitoring — all essential to supporting production campaigns, clinical and commercial supply. As the In-Process Laboratory Co-ordinator you'll ensure testing is delivered to schedule, reviewed in a timely manner and compliance targets are met.

First established in 1976, our Ballydine facility develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. Ballydine was our Company's first site in Ireland, the Ballydine site is our Company's primary small molecule pipeline commercialisation facility globally, operating as a European hub for quality, manufacturing, and engineering. Its highly skilled teams lead the way in the development of new medicines, including innovative treatments for Hepatitis C, HIV and immuno-oncology, the site exports to over 25 countries around the world.

Bring energy, knowledge, innovation to carry out the following:

• Coordinate day-to-day In-Process laboratory activities to meet turnaround times: plan campaigns, allocate resources, manage materials and ensure documentation and electronic data is in order.
• Ensure all testing activities comply with cGMP, DI requirements, site QMS and safety/environmental rules.
• Write, maintain and electronically build In-Process testing methods for: In-Process/intermediate testing, bulk solvent tankers, recovered solvents, drug substance/product and SDI cleaning, and environmental testing.
• Approve test specifications and keep LIMS, Empower interfaces and other lab systems current.
• Perform real-time technical review (second-person electronic review) of In-Process/intermediate batches, solvent tankers, cleaning and environmental/utility data to support timely disposition.
• Compile analytical packs for Quality review and disposition.
• Raise and manage change controls and support deviation investigations (QNs), root cause analysis and CAPA implementation.
• Support troubleshooting of lab systems (GLIMS/Empower/LabX/Tiamo and standalone instruments) before escalation.
• Drive MPS/continuous improvement initiatives to increase RFT, reliability and efficiency.
• Coordinate training to ensure analysts/technicians are competent and compliant.
• Prepare and deliver required laboratory metrics, CPV reports and APR inputs on time.
• Act as main auditee and support internal and external regulatory inspections for the In-Process area.
• Ensure availability of standards, reagents and consumables for testing campaigns.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Minimum BSc in Chemistry or related Life Sciences discipline.
• Solid analytical laboratory experience in a cGMP environment (In-Process/intermediate, solvents, cleaning validation, environmental/utility testing preferred).
• Strong knowledge of GMP, quality systems, change control, deviation management and current regulatory expectations.
• Hands-on experience with LIMS, Empower, Tiamo/LabX or similar chromatography/data systems; competent with Word, Excel, SAP and other lab/quality applications.
• Excellent organisation, planning and time-management skills — able to juggle campaigns and deadlines.
• Strong written and verbal communication; confident report writing and stakeholder engagement across manufacturing, QA, CDS and supply chain.
• Demonstrated problem-solving and continuous improvement skills; experience leading investigations and implementing CAPAs.
• Team player with the ability to work cross-functionally and to deputise for the Team Lead when required.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.