• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • [email protected]
  • North Valley Business Centre, Cork, T23 KC67, Ireland     +353 21 206 6178     [email protected]
  • Analytical Chemist – Co. Waterford

    Role Summary:

     

    • 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
    [email protected]

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.