MOS Biotech Process Specialist.

job details

summary.

  • specialism
    industry
  • contact
    Caterina Del Vecchio
  • reference number
    129085-40135

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job details

In this role, you will join our Manufacturing Operational Support (MOS) service.

You will be a key member of a team responsible for developing technical solutions, optimizing the Manufacturing platform, and integrating new molecules. You will act as a catalyst and facilitator for organizational and operational initiatives related to efficiency, productivity, reliability (obsolescence, technology watch), compliance, cost and energy considerations. This is an excellent opportunity to gain exposure to a wide variety of manufacturing techniques, including fed-batch, intensified, and continuous processes across different manufacturing suites and products (commercial and clinical).

Key Responsibilities:
  • Participate in cross-functional projects and task forces, including the tech transfer of new molecules, implementation of new technology, continuous improvement, and major non-conformity investigations.
  • Identify opportunities, build business cases, and promote the deployment of new technology.
  • Ensure complete adoption of changes in the field in a tactful and diligent manner, monitor effectiveness, and ensure compliance with EHS and cGMP requirements (including management of change controls, corrective & preventive actions in the QMS system, writing and/or reviewing project charters, risk analysis, protocols, and reports as appropriate).
  • Foster harmonization, synergies, and ensure consistency between different production units.
  • Support the definition of design requirements (URS), testing, qualification, and documentation of project activities as required.

In this role, you will join our Manufacturing Operational Support (MOS) service.

You will be a key member of a team responsible for developing technical solutions, optimizing the Manufacturing platform, and integrating new molecules. You will act as a catalyst and facilitator for organizational and operational initiatives related to efficiency, productivity, reliability (obsolescence, technology watch), compliance, cost and energy considerations. This is an excellent opportunity to gain exposure to a wide variety of manufacturing techniques, including fed-batch, intensified, and continuous processes across different manufacturing suites and products (commercial and clinical).

Key Responsibilities:
  • Participate in cross-functional projects and task forces, including the tech transfer of new molecules, implementation of new technology, continuous improvement, and major non-conformity investigations.
  • Identify opportunities, build business cases, and promote the deployment of new technology.
  • Ensure complete adoption of changes in the field in a tactful and diligent manner, monitor effectiveness, and ensure compliance with EHS and cGMP requirements (including management of change controls, corrective & preventive actions in the QMS system, writing and/or reviewing project charters, risk analysis, protocols, and reports as appropriate).
  • Foster harmonization, synergies, and ensure consistency between different production units.
  • Support the definition of design requirements (URS), testing, qualification, and documentation of project activities as required.

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Caterina Del Vecchio

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