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Senior MS&T Scientist

  1. Dublin
County Dublin
  1. Contract
Competitive
  1. CAPEX Projects
18-03-2024
33685
Senior MS&T Scientist - 12 months -Dublin with Travel into the EU

Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a globally renowned biotechnology organisation, and voted one of the top 10 best companies to work for in Ireland, is looking to recruit a Senior Scientist, Parenteral Drug Product MS&T, External Manufacturing to join their team.

As a Senior Scientist, Parenteral Drug Product MS&T, External Manufacturing, you will join our client’s state-of-the-art manufacturing facility to provide technical support for manufacturing of small molecule drug products at Contract Manufacturing Organizations (CMO’s) in Europe. The individual will act as single point of contact for technical matters at the CMO and may perform Person in Plant duties (PIP) in support of commercial manufacturing activities.


Key Responsibilities: 
  • Provide technical support and leadership to the External Manufacturing Organization (ExM) for manufacturing of Parenterals at Contract Manufacturing Organizations (CMO's).
  • The individual will act as single point of contact for technical matters at the CMO and may perform Person in Plant duties (PIP) in support of commercial manufacturing activities.
  • Ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX), etc to reduce supply risks.
  • Employment of resources and processes (OPEX etc.) to improve processing efficiency and to ensure optimized technical support for manufacturing, technical transfer and scale-up of processes to commercial scale.
  • Maintain current knowledge of technology to support successful operation of the ExM business unit.
  • Technical input, authoring, and approval of CMC documents, support CMC query resolution with Global Health Authorities, and support of plant inspections.
  • Participation on various matrixed teams to drive technical process improvement strategies.
  • Support operational management of CMO as per Virtual Plant Team (VPT) governance structure.

Requirements: 
  • A bachelor’s degree in relevant engineering or science discipline (chemical/mechanical/bioprocess engineering, biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Advanced degree is preferred.
  • Advanced knowledge in sterile drug product manufacturing (liquids, lyophilized products, suspensions).
  • The role holder will have in depth understanding of engineering, analytical and regulatory (current Good Manufacturing Practices (cGMP)), Environmental Health and Safety (EHS) aspects of drug product (DP) manufacturing, validation, quality systems, equipment innovations, upgrades, and instrumentation. Ability to work on own and as part of a team and to drive issues to resolution.
  • Demonstrated capability to design, author, and execute process development, qualification, and validation protocols (e.g. PPQ) consistent with current Global Health Authority requirements.

If this role is of interest to you, please apply now! 


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