High Salary: Senior Manager Process Development and Validation

2 weeks ago

Dublin, Dublin City, Ireland beBeeProcessDevelopmentManager Full time €100,000 - €140,000
Senior Manager Process Development and Validation

Job Description:

We are seeking an experienced Senior Manager to lead our Process Development and Validation team. As a key member of our organization, you will be responsible for ensuring the development and validation of processes meet the highest standards of quality and regulatory compliance.

Your primary focus will be on managing a team of tech transfer engineers/scientists, leading tech transfers of new products into commercial production, and providing technical support to manufacturing operations. You will also be responsible for developing and implementing process validation strategies, ensuring adherence to cGMPs and other worldwide regulatory requirements.

The successful candidate will have at least five to ten years of experience in a pharmaceutical or biotech industry, with a proven track record of leading teams and managing complex projects. You will possess strong problem-solving skills, excellent oral and written communication skills, and the ability to provide leadership to cross-functional teams.

Key Responsibilities:

  • Manage a team of tech transfer engineers/scientists and lead tech transfers of new products into commercial production.
  • Develop and implement process validation strategies to ensure adherence to cGMPs and other worldwide regulatory requirements.
  • Provide technical support to manufacturing operations, including troubleshooting and resolving issues related to drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation.
  • Collaborate with cross-functional teams to advance complex projects to completion, ensuring timely delivery of high-quality results.

Requirements:

  • Bachelor's degree in Science, Engineering, or a relevant Quality discipline, with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Strong problem-solving ability, excellent oral and written communication skills, and the ability to provide leadership to cross-functional teams.

Preferred Qualifications:

  • PhD or Master's degree in Science or Engineering.
  • 5+ 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 design, implementation, and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
  • Project management skills, including the ability to manage multiple projects and evaluate project resource requirements.

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