Senior Process Development Manager

6 days ago

Dublin, Dublin City, Ireland beBeeProcessDevelopment Full time €120,000 - €138,000
Job Title:

Senior Process Development Manager

About the Job:

We are seeking a highly skilled and experienced Senior Process Development Manager to lead our process development efforts. In this role, you will be responsible for leading cross-functional teams to develop and characterize new drug product processes, as well as transfer technology to commercial drug product sites.

You will provide technical support to large molecule and small molecule drug product manufacturing, and contribute to product quality assessments and process flow documents. Additionally, you will lead or assist in deviation and exception resolution and root cause analysis.

This is an excellent opportunity for a seasoned professional to join our team and make a significant impact on our process development activities.

Key Responsibilities:
  • Lead cross-functional teams to develop and characterize new drug product processes
  • Transfer technology to commercial drug product sites
  • Provide technical support to large molecule and small molecule drug product manufacturing
  • Contribute to product quality assessments and process flow documents
  • Lead or assist in deviation and exception resolution and root cause analysis
Requirements:
  • Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role
  • Knowledge of cGMPs and other worldwide regulatory requirements
  • Problem solving ability and excellent oral and written communications skills
Preferred Qualifications:
  • 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 knowledge of Quality systems, Drug Product Manufacturing and Validation
Benefits:

We offer a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.

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