Maintain process knowledge database for Chemistry and Conjugation including related raw materials, scale, impurities and data analysis using statistical or other methods.
In collaboration with CMO partners, conceive and devise experiments to test process changes and analyze the results through statistical means or otherwise. A familiarity with OFAT and DoE experimental design and analysis is a bonus.
Provide technical support for Chemistry and/or Conjugation process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.
Work collaboratively with Analytical Development, Project Management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers to achieve corporate objectives
Clearly and efficiently communicate in both written and verbal forms with managers, peers, and external partners.