Expert Analytical Specialists

Expert Analytical Specialists (Shift) are required on a PERMANENT basis by CareerWise Recruitment for our Cork based Biopharmaceutical Client.

These positions will be based within the analytical group supporting Peptides manufacturing. Following appropriate training, the successful candidates will work a Full Rotation shift pattern (operating on a 24/7 basis – 2-days, 2-nights, 4 days off).

As a member of the Quality Control Laboratory, the QC specialist is primarily responsible for conducting various analytical tests/assays to determine the identity, quality and purity of various pharmaceutical-related analytes. For these roles, this will involve primarily supporting In-process testing for Peptides manufacturing. Driven by business needs, the need for occasional support for testing outside of the Peptides In-process labs may also arise. This may include testing support within the Small Molecule In-process lab or testing support for raw materials, intermediates, final products/batch release, reference standard characterisation, investigative/non-routine samples etc., or validation of new methods to support new product introductions (NPIs).

All work is conducted in accordance with current Good Manufacturing Practice (cGMP) requirements. Typical analytical techniques and equipment utilised as part of the role would include high performance liquid chromatography (including online HPLC/PATrols), gas chromatography, Karl Fischer titrators.

The QC Specialist will normally work under the technical supervision of an Analytical Chemist, who will provide technical oversight for the analytical testing.

THE ROLE:

• Conducting various analytical testing as specified above (including second person verification) in accordance with cGMPs
• Maintaining the laboratory facility, supplies and equipment in an inspection-ready state, and supporting regulatory inspections where required
• Conducting and documenting Quality observations and investigations to completion
• Tabulating and consolidating assay results, lead times and other performance indicators and presenting informal reports of results to immediate supervision
• Using Lean methodologies and participating in continuous improvement projects
• Participating in laboratory and facility processes including safety audits, procedure revision, housekeeping and improvement projects, and liaising with other departments as necessary
• Qualification and routine maintenance of various analytical instrumentation including PAT (Process Analytical Technology)
• Acting as a technical resource (subject matter expert) for analytical technologies
• Training of other personnel in Analytical techniques
• Adhering to Environmental, Health and Safety (HSE) procedures and involvement in HSE incident investigations as needed

REQUIREMENTS:

• Minimum BSc (Hons) in Analytical Chemistry, Chemistry, Biochemistry or a related Laboratory Science subject required.
• Minimum 2-years’ experience with the analytical methodology specified above within a GMP setting.

Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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