Cross-Functional Specialist in Pharmaceutical Operations

1 week ago

Dublin, Dublin City, Ireland beBeeSpecialist Full time €95,000 - €115,000

Job Title: Cross-Functional Specialist in Pharmaceutical Operations

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In this key role, you will be responsible for providing process development support to new product introductions (NPI) and lifecycle management (LCM) changes. You will work closely with cross-functional teams to advance complex projects to completion.

Main Responsibilities:

  • Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
  • Develop process validation plans and process performance qualifications for vial and syringe filling.
  • Ensure all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training.
  • Participate in process validation cross-functional teams.

Requirements:

To be successful in this role, you will need:

  • At least 3 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 (PpK/batch homogeneity), and/or lyophilisation processes.
  • Knowledge of protein biochemistry regarding chemical and physical stability.
  • Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.
  • Strong knowledge of Quality systems, Drug Product Manufacturing, and Validation.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
  • Excellent communication skills.

Benefits:

This role offers a unique opportunity to work in a dynamic environment with a market-leading biopharmaceutical company based in Dublin, Ireland. You will have the chance to develop your skills and expertise while contributing to the success of our operations.

Key Skills:

The ideal candidate will have a strong background in pharmaceutical operations, process development, and validation. They will also possess excellent communication and leadership skills, as well as the ability to work effectively in a cross-functional team environment.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for career growth and professional development.

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