Senior Process Development Scientist

6 hours ago

Dublin, Dublin City, Ireland beBeeProcess Full time
Job Title: Senior Process Development Scientist

We are seeking a skilled and experienced Senior Process Development Scientist to join our team. As a key member of our technical services team, you will play a crucial role in supporting commercial manufacturing and technology transfers.

Job Description

The successful candidate will be responsible for:

  • Supporting commercial manufacturing to meet commercial requirements, including investigations, process robustness and process improvements.
  • Scaling up mammalian cell culture processes from bench and pilot scale to a large-scale 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 the Grange Castle site.
  • Providing independent decision making for strategic input into facility and equipment design.
  • Preparing, reviewing and executing technology transfer protocols, supporting documentation, 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.

You will work closely with the management and technical team to identify best practices, technical transfer efficiencies and optimisations during technical transfer.

Requirements

To be considered for this role, you must have:

  • A minimum of 3-6 years of experience in mammalian cell culture process development, late-stage characterisation and technical transfer or technical services in stainless steel and/or single-use facilities.
  • Demonstrated history and in-depth knowledge of cell culture scale-up practices, 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.
Skills

We are looking for someone with:

  • 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.
  • Effective communication, planning and organisation skills to deliver documentation.
Work Environment

This role will be based in our state-of-the-art facility in Dublin, Ireland. You will be part of a dynamic and collaborative team that values innovation, teamwork and customer focus.

Please note that to be eligible for this position, you must be legally entitled to work in Ireland.

How to Apply

If you are a motivated and talented professional who is passionate about process development, we encourage you to apply for this exciting opportunity.

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