Process Development Scientist

2 weeks ago

Dublin, Dublin City, Ireland beBeeProcess Full time €60,000 - €80,000

Job Title: Process Specialist

Location: Dublin, Grange Castle

Cpl in partnership with Pfizer Grange Castle are hiring for an 11-month contingent contract.

About the Role:

The Technical Services team are seeking an experienced process scientist whose role will focus on supporting commercial manufacturing and technology transfers to the drug substance manufacturing facility. This role will be located at the Pfizer Grange Castle site.

This position will report to the Technical Services Lead and will be an integral part of a high performing technical services team whose role will involve:

  • 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 & 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.
  • Partnering with the management and technical team to identify best practices, technical transfer efficiencies and optimisations during technical transfer.
  • Developing and maintaining effective working relationships with other division groups supporting technology transfer, validation and process support.

Requirements:

  • A minimum of 3 - 6 years of process development/ late-stage characterisation and technical transfer / technical services experience in single use systems.
  • 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.

Key Skills:

  • High technical capability, interpret complex data, problem solving and technical learning.
  • Promoting information sharing and excellent interpersonal skills.
  • Capability of working in a multi-disciplinary team environment to tight timelines.

What We Offer:

  • A challenging role with opportunities for professional growth and development.
  • A collaborative and dynamic work environment.
  • Competitive salary and benefits package.

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