\\n Are you looking forward to join a highly motivated CMC team and to support all product development & manufacturing programs? Then keep reading!
Tasks
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\\xe2\\x80\\x99s and CMO\\xe2\\x80\\x99s
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.
SwisSolution Human Capital AG
Die richtigen Talente zu erreichen, begeistern und zu gewinnen ist eine grosse Herausforderung.
Sie zu meistern, erfordert kluge K\\xc3\\xb6pfe, umfangreiche Technologie und Zugang zur Zielgruppe.
Mit der SwisSolution erhalten Sie genau dies!\\n \\n \\n \\n \\n \\n