Biologics Laboratory Specialist

6 days ago

Dublin, Dublin City, Ireland beBeeBioanalytical Full time €45,000 - €65,000

We are seeking a highly skilled QC Bioanalytical Analyst to join our team at Life Science Recruitment. The successful candidate will be responsible for performing analytical testing within the Biologics laboratory.

Key Responsibilities:
  • Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis (CE), PCR testing, Bioassay methods (ELISA methods) and a wide range of compendial methods on Release, In-process, Stability samples in compliance with GMP requirements.
  • Executing and Supporting routine analytical testing with Raw materials onsite.
  • Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
Requirements:
  • 1 - 5 years laboratory testing experience in the Pharmaceutical or Biopharmaceutical industry.
  • Qualification in Science/Chemical Engineering/Biological Engineering.
  • Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Knowledge of cGMP & Laboratory Quality Systems.

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