Biologics Scientist – 12 Months FTC | Collins McNicholas

Biologics Scientist – 12 Months FTC

  • Reference: GY45437
  • Job Type: Permanent
  • Location: Mayo
  • Category: Science, Pharmaceutical & Food

Responsibilities:

• Leading the DS2 Phase 3 project to ensure all deliverables are completed on time for Phase 3 manufacture in Q218.

• Project lead and point of contact for meetings internally and external to site.

• CMC DP Westport lead for Phase 3.

• Review and Approval in an SME capacity of GMP documentation (e.g. SOPs, methods, Master records, Batch Records etc.). 

• Knowledge of analytical requirements will help facilitate a holistic view.

• Support regulatory filing updates.

• Work closely with Manufacturing, Analytical, Biologics Product Development (Irvine) and various site functions to ensure the project is delivered on time.

 

Skills and requirements:

• 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.

• Excellent technical writing and communication skills.

• Proven ability to problem solve.

• People management skills essential

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

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

• Participates in process and quality risk assessments.

• Supports technology transfer activities.

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

• Good technical writing skills.

• Excellent communicator.

• Understanding of OPEX

• Excellent planning and organisational skills.

• Working knowledge of Quality Management System (QMS)

• Knowledge of clinical development phases and associated 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
  • Connect with Amy

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