Head Operations Strategic Growth Project
vor 1 Woche
We are looking for an Operations Head for the new sterile Drug Product Manufacturing facility in a Capital investment project for building and commissioning of the manufacturing, warehouse and quality control unit (Dolphin).
You will have the overall responsibility for the performance of the Drug Product manufacturing facility and achieving the requested manufacturing goals.
Ensuring products and/or services are executed safely within the expected quality and compliance (cGMP).Key responsibilities- Secure the operational readiness of the new facility and for its operative takeover (after operational qualification, before performance qualification) and integration into the overall manufacturing network- Ensure timely end-user input throughout all phases of the project, to secure that the operational and maintenance point of view / expertise are shared with the design team- Integrate the lead operating and maintenance personnel in the technical solution definition and thus ensures operations' acceptance- Ensure that operation teams are built up early enough to allow allocating staff to the C&Q activities for getting familiar with functionalities of equipment and installations and acquire in-depth technical understanding- Ensure facility and utilities readiness with the team, covering all systems and infrastructure that are required for operating the plant such as clean and black utilities, HVAC, clean rooms, maintenance, waste handling - but also office areas, housekeeping, warehouse space, material sampling areas, logístical movements; For aspects already covered by the existing Stein site in close collaboration with the site- Implement the LONZA culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside the own area of responsibility- Full responsibility for all aspects of human resource management such as qualification, development, coaching, hiring, pay decisions and discipline issues- Responsible for preparing the budget of the unit and preparing lumpsums, CARs and upon approval ensuring their execution accordingly to plan and budget- Responsible for control of own cost center, identify and implement cost reduction measures- Developing department goals, strategy and prioritize with respect to overall goals of Lonza
Key requirements:
- University degree (PhD or MSc) in Pharmaceutical sciences, chemistry, or process engineering, or related fields or equivalent
- Significant work experience in sterile DP manufacturing and Aseptic product manufactures (clinical product and/or commercial product)
- Proven knowledge of cGMP compliance requirements
- Prior experience in the design and building and rampup of a DP Sterile Facility (aseptic)
- International experience and experience in "large pharma"
- Business fluent in English and German
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
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