25126 SPR Subject Matter Expert (Scientist)

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards25126 SPR Subject Matter Expert (Scientist)

• Conduct projects of SPR analytical method establishment (setup, development, transfer, GMP validation) within a team 
• Writing SOPs, protocols and reports for the given SPR analytical method establishment 
• Collaborate with different stakeholders, intra-team, inter-teams (typically with customer managers or QA) and external (e.g. customer or suppliers) for SPR projects 
• Support in routine testing 
  • Planning of the assays 
  • GMP review 
  • Stock management 
  • Training of the analysts 
  • Support in lab work when needed 
• Responsibility of SPR device (Biacore)

• Master's degree in biology or biotechnology, or equivalent 

• Extended experience in SPR (preferentially with Biacore) - minimum 5 years

• Great GMP aptitude (comfortable with GMP investigation for deviations, non-conformities or OOS) 

• Regulatory knowledge regarding SPR analytical method development and validation (ICH Q2)

• Experience in immunoassay and/or cell-based assay is a plus 

• Great writing skills and enjoying the strategic thinking 

• Solution orientation, proactivity and joy at work 

• Great team spirit and communication 

• Autonomy at work