Administration/Operations Director, JN-International Medical Corporation: 2004 to Present
Assisted CEO in business operations including working with vendors and setting up R&D facility.
Coordinated Phase 1 meningococcal vaccine trial. Coordinated staff hiring, training, and safety.
Coordinated waste disposal and provided required documentation to state and local regulatory agencies for QC and production facilities.
Chief Scientist JN-International Medical Corporation: 2009-present
Developed, optimized and performed PS-DT conjugation, downstream processing of meningococcal PS, methods of glycan impurity removal from DT as a polishing step. Prepared, purified and characterized PS-diphtheria toxoid conjugates for a quadrivalent vaccine for clinical trials. Performed NMR characterization of polysaccharides at local UNMC Eppley NMR facility. Developed chromatographic protocols for vaccine potency and stability and performed stability testing. Contributed to and reviewed CMC for IND submissions.
Set up and assisted with validation of serum bactericidal assays using human or rabbit complement (rSBA and hSBA) for meningococcal antibodies at a contract laboratory and in-house. Evaluated SBA data for pre-clinical and human vaccine trials. Evaluated SBA data for pre-clinical and human vaccine trials. Supervised and trained associates.
Chief Scientist Fermentation Engineer, JN-International Medical Corporation: 2011-present
Designed and carried out cost-effective fermentation, production and upstream purification of polysaccharides and diphtheria toxoid for conjugate vaccines, including scale-up, media testing, and assisting with upgrading facilities to meet cGMP compliance and other US FDA requirements. Supervised and trained associates. 98-2000
Chief Engineer, JN-International Medical Corporation: 2009-present
Maintained and upgraded production and quality control/office buildings and facilities, including purified water and water for injection systems, boilers, electrical, backup generators, refrigeration, heating, cold rooms, clean rooms, SCADA monitoring system, safety and security.
Assisted with documentation and upgrades for GMP standards. Supervised and trained assistants.
Principal, Ann Sutton Consulting; 2012-present
Consulting in regulatory affairs and product development of biologic products. Gap analysis, writing and/or editing of regulatory submission, evaluation of GMP compliance according to stage of product development and development of CAPA plans, customized training.
Previous Experience: 20 years with FDA
Senior Consultant; Vice President for Bacterial Products, Biologics Consulting Group, Inc.; 1998 to 2012
Associate Director for Regulatory Affairs, Division of Bacterial Products. CBER, FDA; 1991-1997
Microbiologist Divisions of Biological Investigational New Drugs, OBRR (later CBER), FDA; 1987-1991
Microbiologist, Division of Bacterial Products. Bureau of Biologics, FDA (later OBRR); 1971-1987
Microbiologist, Division of Virology, Division of Biologics Standards, NIH; 1970-1971