Experience

MacroGenics, Inc.

• United States
• Biotechnology Research
• 200 - 300 Employee

• Director Validation at MacroGenics, Inc

  • Feb 2019 - Present

• Associate Director Validation

  • Apr 2014 - Feb 2019



Canon U.S. Life Sciences, Inc.

• Rockville, MD

• Manager of Validation

  • Jul 2013 - Apr 2014



Paragon Bioservices, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director Validation Project Management

  • Jul 2012 - Jun 2013

  Founded in 1990, Paragon Bioservices is a CMC Center of Excellence delivering research, development and cGMP manufacturing services to pharmaceutical companies, biotechnology companies and federal agencies. Founded in 1990, Paragon Bioservices is a CMC Center of Excellence delivering research, development and cGMP manufacturing services to pharmaceutical companies, biotechnology companies and federal agencies.



Valneva

• France
• Biotechnology Research
• 400 - 500 Employee

• Head of Engineering, Maintenance, & Validation

  • Jan 2011 - Sep 2011

  Coordinated defined shutdown of validated cGMP facility in manner designed to reduce validation impact upon restart to GMP status. Developed validation turnover package required to bring manufacturing plant back to cGMP status resulting in 3 month decrease in project timeline. Facilitated team responsible for identifying potential product development paths resulting in 4 candidate products

• Head Quality Assurance Validation

  • Sep 2009 - Jan 2011

  Led department responsible for a) creating master validation plans for computerized systems, manufacturing processes, analytical methods, facility renovation, cleaning and spreadsheet; b) all aspects of validation for facility, utilities, and equipment (FAT, SAT, IQ, OQ, PQ) and cleaning; and c) equipment and assays for Quality Control and clinical laboratory equipment. Created program schedule and managed validation contractors. Completed work under budget



Iomai Corporation

• Biotechnology Research
• 1 - 100 Employee

• QA Manager Manager, Validation

  • May 2007 - Sep 2009

  Responsible for transforming a validation program for a phase 1/2 vaccine candidate to a full validation program for phase 3 product. Developed strategy, performed gap analysis which identified weaknesses leading to improved quality systems necessary to support validation program. Resulted in focused attention on validation with improved documentation, a revised CAPA SOP and a risk management program Responsible for transforming a validation program for a phase 1/2 vaccine candidate to a full validation program for phase 3 product. Developed strategy, performed gap analysis which identified weaknesses leading to improved quality systems necessary to support validation program. Resulted in focused attention on validation with improved documentation, a revised CAPA SOP and a risk management program



DVC a CSC Company

• Project Manager

  • Mar 2002 - May 2007

  Directed cross functional team responsible for validation of the manufacturing process for purified drug substance, acted as communications manager between team and subcontractor, and ensured work in scope and new work properly authorized. Designed quality systems. Managed internal quality. Directed cross functional team responsible for validation of the manufacturing process for purified drug substance, acted as communications manager between team and subcontractor, and ensured work in scope and new work properly authorized. Designed quality systems. Managed internal quality.



Phoenix Imperative

• Consultant

  • 1998 - 2002

  Managed installation, operational, and performance qualifications of equipment in the pharmaceutical industry. Designed, wrote and managed the execution of process validation protocols. Performed cGMP audits. Directed IT solutions for office. Managed installation, operational, and performance qualifications of equipment in the pharmaceutical industry. Designed, wrote and managed the execution of process validation protocols. Performed cGMP audits. Directed IT solutions for office.



Sienna Biotech

• Team Manager/Chemist

  • 1997 - 1998

  Directed project team responsible for a 2nd generation instrument designed for quantitative assays. Ensured device cGMP were addressed. Managed development activities of engineering and assay teams on aggressive time line. Designed highly sensitive multiple antigen assay. Supervised up to 4 scientists. Directed project team responsible for a 2nd generation instrument designed for quantitative assays. Ensured device cGMP were addressed. Managed development activities of engineering and assay teams on aggressive time line. Designed highly sensitive multiple antigen assay. Supervised up to 4 scientists.



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Scientist Project Manager

  • 1982 - 1996