We are looking for a Principal Scientist/Analytical Project Leader with experience in Drug Product Analytics. The position is based in Basel.
- As a Subject Matter Expert you will represent Drug Product Analytical discussion with internal as well as external stakeholders.
- Set up Drug Product Analytical Strategy, by ensuring timelines and project deliverables are visible and accessible by all parties.
- Manage development and evaluation of analytical methods and technologies to support formulation development and Drug Product testing (GMP and non-GMP, specifically including HPLC and CE purity methods, content by UV, color, clarity and opalescence, pH, osmolality, extractable volume, CCI, visual inspection).
- Adhere to cGMP regulations as requiredOversee delivery of analytical milestones and maintain up to date knowledge of assigned molecules as well as newest developments in industry and pharmacopeia.
- PhD degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Working experience in analytical development or QC with GMP experience
- Very good working knowledge in all relevant analytical techniques as well as sound ability to interpret complex analytical data
- Experience with parenteral dosage forms and protein analytics
- Experience with analytical lifecycle for biotechnology products, CMC requirements for regulatory filings and working in a matrix organization highly desired