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.
- 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.