Process Development Scientist

2 weeks ago

Dublin, Dublin City, Ireland beBeeProcess Full time €75,000 - €98,750

Technical Services Process Scientist Job Opportunity

We are seeking an experienced process scientist to join our Technical Services team. The role will focus on supporting commercial manufacturing and technology transfers.

  • Supporting commercial manufacturing to meet commercial requirements, including investigations, process robustness, and process improvements.
  • Scaling up processes to the manufacturing facility.
  • Performing, presenting, and executing facility fits, mass balance generation, equipment sizing, gap assessments, and mitigation of operational challenges foreseen to ensure an equivalent process is transferred to Grange Castle.
  • Providing independent decision making for strategic input into facility and equipment design.
  • Preparing, reviewing, and executing technology transfer protocols, supporting documentation, manufacturing batch records, design of experiments, and at scale process trials to deliver an efficient technology transfer.
  • Authoring and reviewing responsible sections of regulatory dossiers, including health authority query responses.

The ideal candidate will have a minimum of 3-6 years of process development/late-stage characterisation and technical transfer/technical services experience in single-use systems.

Key Requirements:
  • Demonstrated history and in-depth knowledge of technical transfer, facility fit, equipment sizing, and mass balance generation for clinical/commercial manufacture.
  • Knowledge and experience of process validation strategies, studies, and requirements.
  • Knowledge of regulatory submissions and response of queries from health authorities.
  • In-depth knowledge of cGMP regulatory requirements related to the design and control of drug substance processes.
  • High technical capability, interpret complex data, problem-solving, and technical learning.
  • Promote information sharing and excellent interpersonal skills.
  • Capability of working in a multi-disciplinary team environment to tight timelines.
Benefits:

As a member of our Technical Services team, you will have the opportunity to work with a talented group of professionals, develop your skills, and contribute to the success of our organisation.

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