Provide technical analytical expertise for late-stage and commercial projects in compliance with GMP standards
Responsible for method validation and transfer strategies as well as method lifecycle activities
Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
Evaluation and review of technical and regulatory submission documents in a timely manner for approval and market launch of development products
Act as analytical SME by providing expert knowledge for regulatory filings

An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
Industry experience (5+ years) in CMC development/commercial
Background in organic chemistry (synthesis of small molecules and/or analytical chemistry) and/or Biologics product development
In-depth knowledge of analytical techniques in HPLC, GC, mass spectrometry, NMR, and IR techniques for analysis of small molecules
Chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for the analysis of mAbs/ADCs
Cell-based and immunoassays, as well as molecular biology and physicochemical techniques for determining potency and biological activity
Expertise in the definition of analytical control strategies, method validation concepts, and setting specifications for biologics and/or small molecules
Experience in working in intercultural, cross-functional teams
Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
Highly motivated and willingness to work in a fast-paced and fast-evolving environment

Analytical Method Expert – Associate Director, AS&T Lifecycle Management

Key skills