Senior Biologics Scientist

6 days ago

Waterford, Waterford, Ireland beBeeAnalytical Full time
Job Description:

The successful candidate will be responsible for isolating particles from sterile biologics and supporting investigations into particle origin.

The role will involve use of advanced analytical techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy.

Responsibilities include providing analytical chemistry services and support to site operations, performing particle analysis, collaborating effectively with Quality Assurance, Production, Engineering, and Planning departments, and maintaining, updating, and issuing chemical methods, specifications, and SOPs in line with regulatory and pharmacopoeial requirements.

Additionally, the successful candidate will train analysts in relevant methods, SOPs, and technical updates, monitor and trend analytical results, complete COAs, and support OOS investigations.

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

They will also have hands-on expertise with particle characterisation techniques such as FTIR, Raman spectroscopy, and SEM, strong knowledge of cGMP and cGLP requirements, familiarity with method development, validation, and maintenance of SOPs and technical documentation, and ability to conduct and support OOS and deviation investigations.

Strong communication and collaboration skills, with the ability to work across multidisciplinary teams, are also essential.

Join our team and work on our customer site in Waterford. We are seeking a Quality Control Analyst to join our team and help us deliver world-class lifecycle services to regulated and high-risk end markets.

  • Key Responsibilities
  • Provide analytical chemistry services and support to site operations.
  • Perform particle analysis and support investigations into the source of foreign matter.
  • Collaborate effectively with Quality Assurance, Production, Engineering, and Planning departments.
  • 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.
  • Monitor and trend analytical results, complete COAs, and support OOS investigations.
  • Ensure all laboratory records and documentation are accurate, current, and compliant.
  • 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.
Requirements:
  • Education
  • Degree in Chemistry, Analytical Science, or a related discipline.
  • Experience
  • Experience in analytical testing within a GMP-regulated pharmaceutical or biopharmaceutical environment.
  • Skills
  • Hands-on expertise with particle characterisation techniques such as FTIR, Raman spectroscopy, and SEM.
  • Strong knowledge of cGMP and cGLP requirements.
  • Familiarity with method development, validation, and maintenance of SOPs and technical documentation.
  • Ability to conduct and support OOS and deviation investigations.
  • Strong communication and collaboration skills, with the ability to work across multidisciplinary teams.
Why Join Us?

At Catalyx, we understand that our people are our greatest asset. For this reason and many others, we take care of them.

The team in Catalyx benefits from a Total Rewards package. This includes great professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.

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