Experience

Hyman, Phelps & McNamara, P.C.

• United States
• Law Practice
• 1 - 100 Employee

• Senior Regulatory Device & Biologics Expert

  • Nov 2019 - Present



FDA

• United States
• Government Administration
• 700 & Above Employee

• Consumer Safety Officer

  • Mar 2018 - Nov 2019

  Performed scientific regulatory reviews for Biologics License Applications (BLA), Supplements (PAS, CBE-30), and Pre-Market Approvals (PMAs). Assisted in planning, coordinating, and evaluating the manufacturing review for BLAs, PMAs, and supplements for biological products.Evaluated facility design, operation, manufacturing/testing procedures, and compliance with Good Manufacturing Practices (GMPs). Extensive experience reviewing validation activities for manufacturing equipment and facilities. Participated in multiple FDA inspections of manufacturing facilities as part of the licensing process for BLAs concerning new devices and vaccines (21 CFR 211, 600, and 820). Principal advisor for manufacturing process review for all device files in Manufacturing Review Branch II.Manufacturing Reviewer, CMC Reviewer, and Facility Inspector for the first FDA approved Ebola Vaccine. Show less

• Chemist

  • Aug 2015 - Mar 2018

  FDA - CDRH - Office of In Vitro Diagnostics - Division of Chemistry and Toxicology DevicesTotal Product Life Cycle ExperiencePost-market Duties: Consumer Safety OfficerExtensive experience with the investigation and inspection side of medical device regulation. Spent over a year as the principal advisor for reviewing Establishment Inspection Reports (EIR) and firms’ responses to EIRs for the Division of Chemistry and Toxicology Devices. Led weekly meetings attended by members of multiple divisions within FDA on the proper review of inspection reports. Authored a multi-site Domestic/Foreign inspection guidance that is being completed in 2018. I was the point of contact for all the Office of Regulatory Affairs districts regarding this year long inspection activity.As a Consumer Safety Officer, was tasked with evaluating recalls that are submitted by companies regulated by FDA. Expert on the investigation of complaints from the field.Pre-market Duties: Scientific ReviewerReviewed scientific data submitted in support of a variety of medical device submissions such as pre-market applications (510(k)s, PMAs), applications to determine if a regulatory decision on the safety and effectiveness of the device can be made (Pre-Submissions and Study Risk Determinations). Reviewed Investigational Device Exemptions (IDEs) for new and breakthrough devices to ensure the safety of the patients in the study. Reviewed PMA supplements containing both manufacturing and design changes to approved devices and assessed the validation data provided. Show less



Yale University

• United States
• Higher Education
• 700 & Above Employee

• Postdoctoral Associate

  • Aug 2013 - Jul 2015

  Routinely synthesized new molecules under oxygen and moisture sensitive conditions. Analyzed data to determine reaction intermediates and products from novel reactions. Able to ascertain the identity of an unknown compound using a wide range of analytical chemistry techniques. Well versed in analytical techniques including: Single Crystal X-Ray Diffraction, SQUID Magnetometry, Mossbauer Spectroscopy, electrochemistry, NMR Spectroscopy (1H, 2H, 7Li, 13C, 19F, 31P, COSY, HSQC, and HMBC), IR Spectroscopy, UV-Vis Spectroscopy, and GC/MS. I have fifteen scientific publications and have presented at scientific gatherings eleven times. Show less



UC Santa Barbara

• Higher Education
• 700 & Above Employee

• Graduate Student

  • Sep 2008 - Jun 2013