Analytical Project Leader

  • BioTalent
  • Basel, BS, Switzerland
  • 17/03/2021
Full time Data Science Data Analytics Big Data Data Management Statistics

Job Description

We are looking for a Principal Scientist/Analytical Project Leader with experience in Drug Product Analytics. The position is based in Basel.
Responsibilities:

  • 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.

Requirements:

    • 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