Analytical Scientist – 12 Month Contract | Collins McNicholas

Analytical Scientist – 12 Month Contract

  • Reference: GY45435
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

 Responsibilities:

• Lead Method Transfer and Validation activities associated with biological drug product transfer.

• Compiling of all Laboratory documentaion (e.g. SOPs, methods, Master records, Batch Records, Reports etc.). 

• Good knowledge of instrumentation and method validation  an advantage. 

• Support regulatory inspections as required for clinical product from the WBD function.

 

Skills, Experience and Qualifications:

• MSc degree with three years experience or a degree in a Science or Engineering discipline with five or more years of applied experience in Pharma/ Biologics.

• Experience with commercial & / or clinical manufacture.

• Biologics experience and understanding of bioanalytics an advantage (HPLC, ELISA, Western Blot etc.)

• Support NPI activities and lead various aspects to ensure all necessary processes and procedures are in place to be audit ready.

• Experience with GMP regulatory inspections.

• Experience of managing & coordinating analytical method transfer activities.

• Experience with interacting in project teams at a local/global/corporate level.

• Excellent technical writing and communication skills.

• Proven ability to problem solve.

• A good understanding of cleaning validation (specifically analysis of samples).

• Participates in process and quality risk assessments.

• Lead and co-ordinate technology transfer activities.

• Good technical writing skills.

• Good communicator.

• Good planning and organisational skills.

• Working knowledge of Quality Management System (QMS), Laboratory Information Management Systems (LIMS), Empower.

• Knowledge of clinical development phases and associated analytical requirements.

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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