Experience

Mazen Animal Health - Oral Vaccines
• United States
• Biotechnology Research
• 1 - 100 Employee
• Director of Regulatory Affairs

  • Jan 2021 - Present

EDGE Veterinary Vaccines Consulting Group, LLC
• United States
• 1 - 100 Employee
• Consultant

  • Jan 2019 - Present


Elanco Animal Health

• 1 - 100 Employee

• • Jan 2018 - Jan 2021

  Direct multi-site team of 15 responsible for assay development for large molecule portfolio including vaccine, biopharmecutical, nutritional, and enzyme products. Analytical methods include in-process, characterization, purity, and potency assays for process monitoring and release of commercial serials.

• • Mar 2017 - Jan 2018

  Direct team of 17 responsible for analytical development and process development for veterinary vaccines. In-coming transfer of early phase methods and processes from Research team at another site. Transfer of developed methods and processes into QC and Manufacturing.

• • Jan 2017 - Mar 2017

  Direct staff responsible for innovation and post-license regulatory activities for companion animal vaccines. Obtain USDA approval for 64 acquired products and related facilities. Regulatory responsibility for product transfers out of and into the site. Represent Elanco on technical transfer team comprised of Elanco, BIVI, Merial, and Federal Trade Commission. Leadership role on Ft. Dodge site Transition Team.



Boehringer Ingelheim Vetmedica, Inc.

• Senior Associate Director International Regulatory Affairs

  • Aug 2010 - Dec 2016

  Direct staff of 15 responsible for all NAFTA pre and post-license regulatory activities for veterinary vaccines for all species. Work with Quality leads to represent firm in issues resolution with USDA CVB. From 2010-2014 this team was issued the most new USDA product licenses of all US firms. Direct staff of 15 responsible for all NAFTA pre and post-license regulatory activities for veterinary vaccines for all species. Work with Quality leads to represent firm in issues resolution with USDA CVB. From 2010-2014 this team was issued the most new USDA product licenses of all US firms.



Boehringer Ingelheim Vetmetica, Inc.

• Associate Director, International Regulatory Affairs

  • Dec 2009 - Aug 2010

  Directed staff of 8-10 responsible for all NAFTA regulatory activities for companion animal vaccines. Facilitate transfer of 120 vaccine product licenses (former FDAH products) from Pfizer Animal Health (PAH). Serve as liaison with joint team of USDA CVB, FTC, PAH, and BIVI to ensure efficient transfer of divested assets. Directed staff of 8-10 responsible for all NAFTA regulatory activities for companion animal vaccines. Facilitate transfer of 120 vaccine product licenses (former FDAH products) from Pfizer Animal Health (PAH). Serve as liaison with joint team of USDA CVB, FTC, PAH, and BIVI to ensure efficient transfer of divested assets.



Ft. Dodge Animal Health

• • Feb 2002 - Nov 2009

  Directed staff of 8-10 responsible for all USDA and CFIA regulatory activities. Included new product registration, defense of licensed products, facilities documents, label approval and submission, review of advertising/ promotional material, and import permit acquisition. Managed registration activities resulting in 112 new USDA product licenses that included the world's first DNA vaccine license, the firm's first recombinant vaccine registration in Canada, and three-year duration of immunity claims for vaccines. Show less

• • Jun 2000 - Feb 2002

  Establish formal training department for 1200 employees at three sites. Responsible for coordinating, conducting, and tracking training for all employees including regulatory compliance, SOPs, supervisor and leadership skills, office suite software, and new employee orientation.

• • Feb 1999 - Jun 2000

  Responsible for all aspects of manufacturing of veterinary biologics and sterile injectable pharmaceuticals. Directed team of seventy-five union production employees and fifty technical, supervisory, management, and administrative staff. Coordination and prioritization of operations activities to meet aggressive product demands with minimal staffing.

• • Feb 1999 - Jun 2000

  Oversight of team responsible for preparation and sterilization of viral and bacterial growth media and equipment. USDA/USP/EU compliance for raw material procurement and testing. Consolidation and rationalization of raw materials, solutions, and methods between manufacturing sites (due to acquisition).

• • Feb 1993 - Apr 1998

  Oversight of team responsible for preparation and sterilization of viral and bacterial growth media and equipment. USDA/USP/EU compliance for raw material procurement and testing.

• • Jul 1989 - Feb 1993

  Oversight of technicians conducting in-process and serial release testing of veterinary biologics. Preparation and review of documents submitted in support of release of commercial serials by USDA.

• • Feb 1987 - Jul 1989

  Preparation, expansion, storage, and documentation of working seed virus stocks to provide to manufacturing team.

• • Nov 1982 - Feb 1987

• • Jun 1981 - Nov 1982

  Operation and monitoring of manufacturing scale fermentation equipment.

• • May 1980 - Jun 1981

  Supervise union employees operating packing equipment for veterinary vaccines and filling equipment for veterinary pharmaceuticals.