Senior Technical Operations Leader

1 week ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeDevelopment Full time €90,000 - €120,000
Job Overview

The Process Development Manager is responsible for technical delivery of New Product Introductions (NPIs) and life cycle management (LCM) products. This role requires a strong background in pharmaceutical or biotech industry, with at least five to ten years of experience in leading tech transfers and process validation activities.

A key aspect of this role is the ability to manage a team of tech transfer engineers/scientists supporting new product introductions and lifecycle changes into vial and syringe plants.

Key Responsibilities
  1. Tech Transfer Leadership: Manage a team of tech transfer engineers/scientists supporting new product introductions and lifecycle changes into vial and syringe plants.
  2. Technical Support: Provide technical support to large molecule and small molecule drug product manufacturing.
  3. Process Development: Develop and characterize drug product processes and transfers technology to commercial drug product sites.
  4. Troubleshooting: Troubleshoot issues with drug product processing technologies and equipment.
  5. Risk Assessment: Lead and conduct risk assessment for drug product operations and propose/implement appropriate CAPA.
Requirements
  • Bachelor's degree in Science, Engineering, or a relevant Quality discipline.
  • Minimum five years' experience in a similar role or Master's degree & three years of directly related experience.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem-solving ability and excellent oral and written communications skills.
Preferred Qualifications
  • PhD or Masters in Science or Engineering.
  • Five + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
  • Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.

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