Scientist MSAT – Drug Product Development

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for German and English speaking Technical lead – Drug product development on a 12 months contract based in the Schaffhausen area

 

In this role, 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.
  • You have a 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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