Process Development Specialist

7 days ago

Cork, Cork, Ireland beBeeChemistry Full time €50,000 - €80,000

Job Summary

  • As a Process Chemist, you will provide critical process chemistry support for existing and new processes.

Key Responsibilities

  • Develop and maintain in-depth knowledge of the chemistry of relevant processes, including mechanisms, development history, impurity formation, and control.
  • Support laboratory troubleshooting and investigative activities to ensure efficient process optimization.
  • Lead or participate in thorough technical risk assessments for plant changes and product introductions.
  • Prepare technical documentation, such as manufacturing batch records, laboratory SOPs, and process steps, to support manufacturing operations.
  • Provide training to Operations team personnel on process chemisty principles and practices.
  • Manage and seek approval for all technical changes, ensuring proper communication and documentation.

Requirements

  • Good interpersonal and organizational skills, with ability to work effectively in a fast-paced environment.
  • Excellent facilitation, presentation, and problem-solving skills.
  • Ability to read and understand Standard Operating Procedures, Global Standard Operating Procedures, and Quality standards.
  • Knowledge of cGMP and FDA regulations.

Benefits

  • Opportunity to contribute to process improvement initiatives and drive business growth.
  • Collaborative and dynamic work environment.
  • Professional development opportunities.

Additional Information

  • Must be able to perform duties in a compliant manner and behave in accordance with site SOPs, EHS standards, and guidelines.
  • Perform safety assessments on new materials and processes introduced to the site.
  • Liaise with Thermo Fisher Global Toxicology services/process safety laboratory as required.
  • Participate fully in site quality initiatives and ensure adherence to relevant quality standards.

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