\\n Senior Scientist MSAT - 5482

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Senior Scientist with experience in MSAT on a contract basis in the German speaking part of Switzerland.

In this position, you will establish Manufacturing Science and Technology expertise across different equipment platforms for drug product development & manufacturing with focus on Parenterals.

You will represent the DPDS pilot plant in development and clinical/commercial supply teams ensuring timely clinical supplies for drug product.

Main Responsibilities:

• Ensure timely plant readiness to support experimental / clinical activities
• Ensure timely delivery of clinical material from internal pilot plants
• Provide pilot plant input & requirements to Drug Product Development (DPD) / Primary Container Development (PCD)
• Support scale-up and Tech-Transfer
• Acts as the tech transfer receiving party for pilot plants
• Put relevant manufacturing information and technical capabilities in place for the operations team to flawlessly produce the DP according to GxP, EHS and business requirements
• Ensures that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
• Review qualification documents, calibration, deviation handling and COC. Spokesperson during audits and inspections
• Supports investigations, CAPAs, change controls according to assigned responsibilities and performs critical raw data review for key documents
• Specialist for technology platforms being used within the Pilot Plant & across network

Qualifications and Experience:

Relevant working/residency permit or Swiss/EU-Citizenship required.

• Degree in Pharmaceutical/Biochemical/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (3-5 years) OR a PhD with proven experience (1-3 years)
• Demonstrated proficiency and experience in biologics drug product development within the biopharmaceutical industry is helpful
• Demonstrated proficiency and experience of biopharmaceutical process design is helpful
• Solid understanding and experience of technology transfer operations is preferred
• Solid understanding and experience in fill/finish operations is preferred
• Proven track record of creativity and problem solving.
• Ability to collaborate with cross-functional teams is a must.
• Excellent oral and written language skills in German and English.

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