Senior Biopharmaceutical Chemist

5 days ago

Waterford, Waterford, Ireland beBeeAnalytical Full time €55,000 - €70,000
Job Opportunity: Analytical Chemistry Specialist

Catalyx seeks an analytical chemistry specialist to join their team and work on a customer site in Waterford. The successful candidate will be responsible for isolating particles from sterile biologics and supporting investigations into particle origin.

The role will involve the use of advanced analytical techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy. You will provide analytical chemistry services and support to site operations, collaborate effectively with Quality Assurance, Production, Engineering, and Planning departments.

  • Perform particle analysis and support investigations into the source of foreign matter.
  • Maintain, update, and issue chemical methods, specifications, and SOPs in line with regulatory and pharmacopoeial requirements.
  • Train analysts in relevant methods, SOPs, and technical updates.
Key Responsibilities:

Key responsibilities include monitoring and trending analytical results, completing COAs, and supporting OOS investigations. Ensuring all laboratory records and documentation are accurate, current, and compliant is also crucial.

  • Verify that chemical testing and related equipment meet validation requirements (IQ, OQ, PQ).
  • Review and audit laboratory notebooks, analytical reports, and chemistry test results to ensure compliance with cGLP and cGMP.
  • Identify potential issues and highlight improvements to the QC Team Lead.

The ideal candidate will have a degree in Chemistry, Analytical Science, or a related discipline, with experience in analytical testing within a GMP-regulated pharmaceutical or biopharmaceutical environment.

Strong knowledge of cGMP and cGLP requirements is essential, as well as familiarity with method development, validation, and maintenance of SOPs and technical documentation. Ability to conduct and support OOS and deviation investigations is also required.

Excellent communication and collaboration skills, with the ability to work across multidisciplinary teams, are necessary. Detail-oriented, self-motivated, and adaptable individuals who can thrive in a dynamic environment are encouraged to apply.

Why Work with Us?

We value our people and offer a comprehensive Total Rewards package, including great professional growth opportunities. We strive to create a diverse and inclusive workplace where all individuals are valued, respected, and supported.

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