R&D Analytical Manager

  • Reference: GY45021AO
  • Job Type: Permanent
  • Location: Galway
  • Category: Science, Pharmaceutical & Food
  • Manages the analytical group supporting registration activities
    • Development of staff
    • Sets clear goals and evaluates performance
    • Reports Resource planning to senior analytical manager 
    • Maintains analytical capability/technology to support assigned products
    • Maintains analytical budget and reports to the senior Analytical Director
  • Technical Leadership
    • Sets technical standards to comply with FDA/EMA or regional regulatory requirements
    • Analytical method validation
    • Generates Registration stability data 
    • Preparation of Analytical Registration documentation
    • Sets specifications for a robust shelf life
    • Method transfer to site QC and other sites
    • Chairs the technical meeting to review new stability data
  • EHS
    • Ensures the Analytical registration group operate to EHS standards
  • GMP
    • Collaborates with Quality and Regulatory groups
      • Ensures that the analytical registration group follow quality systems and are fully compliant
      • Ensures that the Analytical laboratories, data, processes and staff are always compliant
  • Perform other duties as assigned.

Qualifications:

  • A minimum of a relevant scientific Bachelor’s degree (additional postgraduate qualifications are advantageous) with 10+ years of applicable experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration.  
  • Must possess knowledge of quality procedures within a highly regulated pharmaceutical laboratory. A strong knowledge of modern analytical techniques is required. Must understand through experience the operation of an API manufacturing plant and associated development laboratory operates.
  • Track record of showing how results were delivered through management/leadership of others. 
  • Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
  • Management of resources and budgets
  • Development and training of team members.
  • Excellent communication skills (verbal and written).
  • Proficient computer skills (Excel, Word, PowerPoint, databases).
  • Proficiency in speaking, comprehending, reading and writing English is required.

 

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

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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