Manufacturing Engineer/Senior Scientist.

☞ Randstad Switzerland

View: 139

Update day: 25-04-2024

Location: Schaffhausen Schaffhausen SH

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Full-time

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Job content

For the Discovery, Product Development & Supply (DPDS) Department located inSchaffhausen, Switzerland we are looking for aManufacturing Engineer/Senior Scientist.
  • Start date: 15.11.2022
  • End: 1 year
  • Extension: possible
  • Workplace: Schaffhausen
  • Workload: 100%
  • Home Office: limited
In this position, you will establish Manufacturing Science and Technology expertiseacross different equipment platforms for drug product development & manufacturingwith focus on Parenterals. You will represent the DPDS Clinical Supply Chain pilotplant in development and clinical/commercial supply teams ensuring timely clinicalsupplies for drug product.Tasks & 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
Must Have
  • 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
  • Excellent oral and written language skills in German and English.
  • 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.
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Deadline: 09-06-2024

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