• Responsible for a project portfolio of up to 4 small projects (typically up to phase 2) or 1-2 highly complex or late stage projects (typically phase 3 and commercial)
  • Representation of AD/QC in technical project team and CMC team meetings
  • Proficiency in immunizations, complex macromolecules, or antibody-drug combinations
  • Development, optimization and implementation of analytical methods
  • Carrying out release, repeat and stability studies, transfer and validation analyses
  • Preparing source documents for IND, IMPD and NDA/MA submissions and responding to regulatory inquiries
  • Creation and review of CoAs, analytical result sheets, specifications
  • Contact for 3rd parties, e.g., CMOs and CROs, for defined analytical tasks
  • Independent evaluation and development of novel analytical techniques and instrumentation
  • Leverages workload of respective project members to assure timelines and budget are met


  • Knowledge of GMP/regulatory requirements and a solid background in analytical chemistry required
  • Experience in analytical development Project Management
  • Basic knowledge of synthetic chemistry, processing of active ingredients and/or formulation development
  • Development and implementation of analytical tests for various active ingredients and products
  • Active search for technical and scientific solutions to improve quality and productivity
  • Excellent problem solving skills and teamwork in diverse teams