MOS Biotech Process Specialist.

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  • categoria
    industria
  • Contatto
    Caterina Del Vecchio
  • riferimento
    129085-40135

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dettagli di lavoro

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.

  • qualifiche

    Your Profile:

    • Strong knowledge in biotechnological processes, detailed manufacturing operations (including automated & execution systems, engineering designs, P&ID, etc.), and new technologies.
    • Pragmatic, solution-oriented, and resilient with the ability to simplify complex technical processes or problems for different audiences.
    • Experience working cross-functionally, interacting with various stakeholders (manufacturing teams on the floor, MSAT, QA, Engineering, EHS, etc.) in a team-based culture.
    • Good communication skills, both written and oral. Fluency in French. English proficiency is a plus.
    • Bachelor's or Master's degree in Biotechnology with initial experience in a cGMP biopharmaceutical environment (manufacturing, MSAT, or development functions) is desirable.
    • This role offers an exciting opportunity for a motivated individual to grow and develop their skills within a dynamic and collaborative environment.

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Caterina Del Vecchio

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