Manufacturing Engineer R&D

For the Discovery, Product Development & Supply (DPDS) Department located in Schaffhausen, Switzerland we are looking for a Manufacturing Engineer/Senior Scientist. 

The resource will be responsible mainly for Technology Transfers.

Position is based on site full time - remote work will be limited if applicable

English & German 

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 Clinical Supply Chain pilot plant in development and clinical/commercial supply teams ensuring timely clinical
supplies for drug product.

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
• Responsible for the electronic master batch records for new products using the site MES system
• 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
• Assess new technologies / applications: feasibility, business case, conceptual design, installation and implementation
• Actively participates in individual or team-based scientific development activities and collaborate in internal / external scientific communities

• You have a degree in Pharmaceutical/Biochemical/Chemical or relevant
  Sciences or comparable experience in pharmaceuticals or in a related field
  with demonstrated ability (5 years) OR a PhD with proven experience (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.