Process Scientist - NPI

31 Jul 2019

Fantastic opportunity for an experienced Process Scientist has opened up in Cork

Fantastic opportunity for an experienced Process Scientist has opened up in Cork. In this role, you will gain experienced working with a leading global biologic's manufacturer.

You will be responsible for leading Technical Transfer, Process Validation, Manufacturing investigations, Life Cycle Management and Health Authority Inspections.

Duties & Responsibilities:

  • Leads early and late phase Technical Transfer activities
  • Leads early and late phase product development
  • Generation of protocols/reports, execution of laboratory scale studies and participation in Lean Early Development initiatives as required
  • Leads "process fit to plant" during early and late stages of development to provide guidance to both development and manufacturing teams.
  • Leads "man in plant" by providing support during manufacturing campaigns for new products or during process validation campaigns.
  • Provides expertise to development teams on manufacturing facility design and capabilities, scale-up considerations and GMP operations.
  • Partner with Project Teams to provide input, review and approval support for BLA submissions
  • Interpret project plans and timelines for CMC projects, and schedule work and experiments to meet these goals.
  • Assist in manufacturing investigations as required, in particular event, deviations and CAPAs, to help meet product release specifications and timelines.
  • Execute experimental plans and protocols to support product life-cycle improvements, process validation requirements, technical transfer projects and development activities as required.

Education and Experienced Required:

  • Minimum Bachelor's degree in Biology, Pharmacy or related scientific field is required
  • Minimum 5 years' experience in pharmaceutical or biotechnology industry.
  • Biological process development or commercial manufacturing experience, either cell culture and/or purification.

Morgan McKinley is acting as an Employment Business in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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