Experience

Imugene Limited

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Sr. Director CMC Regulatory Affairs

  • Aug 2023 - Present

  United States



Precision BioSciences, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Sr. Director, CMC Regulatory Affairs

  • Jan 2021 - Aug 2023

  Durham, North Carolina, United States



Rho

• United States
• Financial Services
• 100 - 200 Employee

• Sr. Director, CMC Regulatory Affairs

  • 2020 - Aug 2023

• Senior Research Scientist

  • 2016 - Aug 2023

  Chapel Hill, NC



Mallinckrodt Pharmaceuticals

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Regulatory Affairs CMC

  • May 2015 - Mar 2016

  Morrisville, NC



Kowa Research Institute, Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, CMC Regulatory Affairs

  • Dec 2012 - Apr 2015

  Morrisville, NC Provided input into drug substance and drug product development plans Reviewed of development data for both drug substance and drug product Authored of CMC related documentation for regulatory submissions Provided input on regulatory strategies related to CMC Performed man-in-the-plant activities at contract manufacturing organizations Participated in FDA interactions



Cato Research

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Pharmaceutical Development

  • 2010 - 2012

  Durham, Norrth Carolina Managed operations of the Pharmaceutical Development group including creation of departmental budgets and ensuring the suitability and accuracy of CMC deliverables. Served as the project manager on various multidisciplinary teams involved with drug products at early stage to midstage in the development process for a variety of indications including, sedation, vitamin replacement, obesity, psoriasis, wound healing, oncology, and infectious disease indications. Primary author of… Show more Managed operations of the Pharmaceutical Development group including creation of departmental budgets and ensuring the suitability and accuracy of CMC deliverables. Served as the project manager on various multidisciplinary teams involved with drug products at early stage to midstage in the development process for a variety of indications including, sedation, vitamin replacement, obesity, psoriasis, wound healing, oncology, and infectious disease indications. Primary author of drug substance and drug product sections for Phase 3 IND for an autologous cartilage replacement biologic-device combination product. CMC management of fixed-dose combination gene transfer drug product for oncology indication. Managed analytical and formulation development program of nasal spray dosage form for vitamin replacement indication. Managed IND preparation and submission of monoclonal antibody-based therapeutic for an infectious disease indication. Managed analytical and formulation development program of solid oral dosage form. Specific activities Managed analytical and formulation development program of lingual spray dosage form for sedation indication. Primary author of IND Module 3 for radiolabeled antibody imaging agent Primary author of CTD Module 3 for solid oral dosage and topical dosage form marketing applications (NDAs) Managing establishment registration activities for pre-NDA radiopharmaceutical Conducted Good Manufacturing Practice audits of active pharmaceutical ingredient (API) and drug product contract manufacturing organizations Performed Quality Assurance review of API and drug product manufacturing batch record

• Associate Director, Pharmaceutical Development

  • 2007 - 2010

  Durham, North Carolina

• Senior Scientist

  • 2006 - 2007

• Scientist

  • 2002 - 2006



Cornell University Duck Research Laboratory

• Production Manager

  • 1996 - 1997

  Eastport, NY Responsible for the production of duck virus hepatitis vaccine, duck virus enteritis vaccine, and a killed-bacteria product (bacterin) that was protective for Pasturella anatipestifer. Responsible for coordinating the assembly of the components of these products with other laboratory personnel, maintaining the cleanliness of the laboratory facilities, sterilization of production materials, lyopholization of final product, record keeping, and submission of production documents and… Show more Responsible for the production of duck virus hepatitis vaccine, duck virus enteritis vaccine, and a killed-bacteria product (bacterin) that was protective for Pasturella anatipestifer. Responsible for coordinating the assembly of the components of these products with other laboratory personnel, maintaining the cleanliness of the laboratory facilities, sterilization of production materials, lyopholization of final product, record keeping, and submission of production documents and product samples to the USDA. Show less



Altana

• Colombia
• Advertising Services

• Microbiologist I

  • 1996 - 1996

  Melville, NY Responsible for the conduct of potency assays for topical antibiotic dosage forms according to USP <81>.



Cambridge Biotech Corporation

• United States
• Hospitals and Health Care

• Manufacturing Technician

  • 1995 - 1995

  Rockville, MD Performed all aspects of retroviral ELISA plate production and serum control production, including inactivation of positive plasmas, manufacture of serum controls, and maintenance and calibration of equipment