- Our client, based in Co. Waterford, is looking for an Analytical Chemist to join their biopharmaceutical facility.
- The Analytical Chemist reports to the Quality Control Manager and is responsible for analytical method transfers, and method validations/verifications, with minimum supervision.
- The candidate will be responsible for troubleshooting any OOS/OOT results that are generated in the Analytical Laboratory.
- The candidate will be responsible for generating and reviewing analytical method validation/transfer protocols and managing laboratory supplies for method transfer/validation.
- The candidate will help prepare and maintain an inspection-ready status within the laboratory to support regulatory audits.
- Experience with analysis of biologics including bioassays is highly desirable.
Core Duties and Responsibilities:
- To perform routine analytical activities as required to support day-to-day laboratory operations.
- To perform analytical testing.
- To prepare and execute method transfer protocols and generate reports.
- To perform method validation/compendial method verification.
- To be actively involved in internal investigations e.g. Laboratory Out of Specifications, Incidents & Deviations etc.
- To ensure that all work is carried out in compliance with the required company standards and conforms to cGxP, relevant SOPs, and safety and environmental guidelines.
- To identify continuous improvement opportunities.
- To Implement Health & Safety requirements as per site documentation including SOPs, Safety Statement
- Report any defects or potential hazards.
Minimum Qualifications and Experience:
- Minimum of Bachelor’s degree in pharmaceutical sciences/chemistry or chemical/bioengineering.
- 5 years experience in the pharmaceutical industry
- Experience in analytical method development, method validations, development, optimization, validation, continuous improvement, troubleshooting, tech transfer, operations, risk analyses/FMEA for drug substance (small molecules), drug product.
- Data analysis and presentation skills
- Problem-solving skills
- Sterile/Biologics experience required.
- Understanding of US, EU, and ICH Good Manufacturing Practices regulation concepts
- Demonstrated leadership in a fast-paced company.
- Team player with Strong interpersonal skills.
- Ability to communicate clearly and concisely verbally and in writing
- Working in the Laboratory as and when required.
- Proficient in Microsoft Office.
- Professional, proactive demeanour.
- Excellent written and verbal communication skills
To Apply: Quote – PE23095
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.