• Validation, technology transfer and resolution of technical issues during cGMP manufacturing
• Manage relationships with CMOs and collaboration partners
• Review and approve regulatory filings, specifications, change controls and master batch records
• Assist with CRO selection and contract negotiations and budgeting
• Advanced degree in chemistry related sciences, i.e., organic synthetic chemistry, medicinal chemistry, analytical chemistry, pharmaceutical sciences or engineering with 5+ years experience in cGMP related CMC drug development or manufacturing
• Must have experience in the preparation of CMC regulatory documentation.
• Must show demonstrated leadership experience in CMC, preferably in more than one related CMC area, and drug development experience with biologics, preferably monoclonal antibodies
• Requires experience in development and validation cGMP chemical manufacture and cGLP analyses
• Must have demonstrated ability to work independently as well as in a team environment
• Excellent communication, writing and presentation skills
Years of Experience: 5+ years Degree: Minimum BA but Advanced degree preferable
Elusys Therapeutics is a privately-held biopharmaceutical company focused on the development of antibody-based therapies for the treatment of infectious disease. The Company has pioneered the development of a rapid injection, anti-toxin antibody, Anthim®, for the prophylaxis and treatment of anthrax disease following a biowarfare attack. Anthim has consistently demonstrated significant efficacy in multiple non-clinical animal studies and has been successfully evaluated in two clinical saftey trials.