Scientist Jobs in Genf

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Organization Overview :

The Active Pharmaceutical Ingredient - External Manufacturing Organization (API EM) TS / MS Person-in-Plant (PIP) Scientist provides the technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, and bulk drug substances. The PIP (Person-in-Plant) scientist position is a remote role, located in Visp, Switzerland.The PIP Scientist provides technical support and oversees the CM facility operations. The PIP scientist is a member of IPT / JPT and contribute as a liaison between the IPT and CM process team.

Responsibilities :

• PIP site support activities : Active member of Joint Process TeamContribute to the technical transfer support activities,Provide process oversight and support,Deviation support and sustainabilityDay-to-day production supports (such as, rig walk-throughs, on the floor daily presence, QA & HSE walkthroughs, ensure practice match procedure, Fit finish and housekeeping walkthroughs),CAPA implementation confirmationOn site support (liaison between production floor and APIEM process team)
• Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
• Execute technical projects (experimental, modeling and / or production data analysis) to improve process control, yield, purity, and / or productivity.
• Provide technical support for preparation of relevant technical documents, as required, such as : technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Develop and monitor established metrics in real-time to assess process variability and capability.
• Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
• Provide support internal and joint process teams and to the global and local PLOT teams.
• Ability to independently set up and execute various chemical reactions.
• Ensure that experiments are well designed with clear objectives
• Ability to analyze data and ensure appropriate documentation
• Utilize save laboratory practice and adhere to CHP requirements
• Write technical reports and documents

Basic Requirements :

Additional Preferences :

Additional Information :

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