Principal Scientist CMC Analytics

☞ SwisSolution Human Capital AG

View: 147

Update day: 22-04-2024

Location: Wädenswil Zürich ZH

Category: Science Labor

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Full-time

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Job content

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

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

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 GlycoEra, CRO’s and CMO’s
  • Ensure capacity sourcing to reach goals according to plans
  • 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
  • Phase appropriate validation of analytical methods
  • 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 GlycoEra molecules for product characterization and GMP release testing
  • Independently planning and executing analytical research projects
  • Maintaining analytical instruments
  • Processing, evaluating, and reporting of data as well as presentation in scientific meetings

Requirements
  • PhD in Natural Sciences or Analytical Sciences
  • 10+ years ‘working experience in the biotech and/or pharma industry
  • Minimum 5 years of relevant analytical/ QC industry experience with GMP exposure
  • 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
  • Well-connected in the analytical technology and instrumentation community
  • Good IT-knowledge (Excel, PowerPoint, databases)
  • 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
  • Personal resilience, perseverance, energy and drive
  • Excellent conceptual and scientific thinking to approach and solve complex issues and their implications
  • Self-motivation and ability to work independently in a fast-pace, small company environment
  • Excellent interpersonal and negotiation skills
  • Team player, collaborative attitude.

Benefits
  • Start-up culture
  • 5 weeks vacation
  • well located office
  • career opportunities

Are you interested and fulfilling the key criteria above? Then please send us your application.
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Deadline: 06-06-2024

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