Senior Drug Product Development Manager

4 days ago

Dublin, Dublin City, Ireland beBeeDevelopment Full time €60,000 - €90,000
Process Development Specialist

We are seeking a skilled Process Development Specialist to support the development of commercial drug product processing in various areas, including aseptic processing, process characterization, technology transfer, and process validation.

Key Responsibilities:
  • Develop as a drug product technical expert, providing leadership and solutions for troubleshooting parenteral drug product manufacturing, from drug substance thawing to transportation of vials and syringes.
  • Work with contract manufacturing partner SME's, Global Operations, Contract Manufacturing Quality, and drug product process teams.
  • Provide expertise for process development, troubleshooting issues with drug product processing technologies and equipment, and identifying operational improvements.
  • Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.
  • Visit contract manufacturing sites to observe production operations and build relationships.
Requirements:
  • 3-5 years' pharmaceutical manufacturing experience in either a drug product or drug substance manufacturing environment.
  • Knowledge of cGMPs.
  • Proven problem-solving ability.
  • Excellent oral and written communications skills.
  • Strong academic results in a third-level bachelor's degree in Science, Engineering, or a relevant quality discipline.
Desirable Qualifications and Experience:
  • Language skills such as Italian or German.
  • Masters or PhD in a Science or Engineering or related discipline.
  • Experience with aseptic drug product processes, component preparation, sterile filtration, filter integrity testing, filling, freeze drying, capping, manual and automated visual inspection.
  • Experience with different aseptic drug product presentations, pre-filled syringes, cartridges, lyophilised vials, and liquid vials.
  • Experience with quality testing methods and interpretation of results for biological molecules.
  • Aseptic drug product validation experience, media fill, sterilisation validation, equipment qualification, process validation.
  • Experience dealing with contract manufacturing organisations.
  • Demonstrated ability to lead and take responsibility.

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