Principal Scientist CMC Analytics [Switzerland]

 Are you looking forward to join a highly motivated CMC team and to support all product development & manufacturing programs? Then keep reading!

Tasks

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• Establish and maintain analytical control strategies for our drug candidates and ensure that relevant assays are implemented in time
• Based on the analytical control strategy define in/ outsourcing concepts between CRO’s and CMO’s
• Development and qualification of GMP compatible analytical assays for release, stability testing and characterization of our drug candidates
• Planning and execution of early formulation and stability studies based on established stability indicating assays
• Analyzing biomolecules such as proteins and glycans (e.g., by U/HPLC, SEC, IEX, mass spectrometry, immunoassays)
• Technology transfer to and oversight of CMOs and CROs tasked with analysis of molecules for product characterization and GMP release testing
• Processing, evaluating, and reporting of data as well as presentation in scientific meetings

Requirements

• PhD in Natural Sciences or Analytical Sciences with 10+ years working experience in the biotech and/or pharma industry
• Minimum 5 years of relevant analytical/ QC industry experience with GMP exposure and broad Experience and knowledge in protein biochemistry and protein analytics, including post translational modifications such as glycosylation
• Hands-on experience in analytical method validation, technology transfer and CMC regulatory analytical matters
• Proven experience in chromatographic analysis of biological molecules including proteins and peptides is a must
• Practical experience with mass spectrometry and data evaluation
• Hands-on experience working with and maintaining HPLC/UPLC instruments
• Experience in statistical data evaluation and high affinity for software tools
• Very good communication skills in English, written and verbal
• Excellent planning and strong organizational skills, able to manage multiple tasks simultaneously and set priorities
• Pro-active and problem-solving attitude and personal resilience, perseverance, energy and drive
• Excellent conceptual and scientific thinking to approach and solve complex issues and their implications

Benefits

• 5 Weeks vacation
• Bonus payment
• Corporate shares
• Startup culture

Our client is biotech company specialized in the development of glycoengineered biologics near Zurich.

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