Experience

R&D Systems

• United States
• Biotechnology Research
• 300 - 400 Employee

• Sr. Director of Global Quality Assurance, Regulatory Affairs and Safety

  • Sep 2018 - Present

• Sr. Director of Quality and Regulatory Affairs

  • Aug 2014 - Sep 2018

• Director, Quality Control

  • Jul 2013 - Aug 2014

  Direct a team of 80 Quality Control professionals. Processes are certified to ISO 9001.

• Manager, Quality Assurance

  • Jan 2009 - Jun 2013

  Manage a team of 10 Quality professionals. Oversee customer complaints, MRB, CAPA and document control systems. Perform customer audits and write audit responses. Author SDS, SOP, COA and COO. Certified Manager of Quality/Organizational Excellence, ASQ-CME/OE, CMDCAS 13485, ISO 13485, ISO 9001, IATA Dangerous Good Shipping.

• Manager, Cell Culture Production

  • May 2000 - Dec 2008

  Managed a department of 20 people responsible for the production of approximately 2500 recombinant protein and antibody products. Used both batch and fed-batch techniques to culture mammalian, insect and hybridoma cell lines in both small- and large-scale cultures (1 - 100 liters). Assisted in the design and managed an animal-free E. coli fermentation laboratory which provided cell paste for over 500 products.

• Scientist, Molecular Biology

  • Jan 1998 - May 2000

  Designed mammalian protein expression vectors for enhancing secreted protein expression; including dual protein expression vectors.



Graduate Women in Science

• Board of Directors

  • 2010 - Jun 2015



3M Pharmaceuticals

• Greater Minneapolis-St. Paul Area

• Biochemist

  • 1987 - 1992

  Developed bioassays for asthma drug development high throughput screening (HTS). Techniques included enzyme purification, cell culture, RIA and HPLC. Developed bioassays for asthma drug development high throughput screening (HTS). Techniques included enzyme purification, cell culture, RIA and HPLC.



St. Paul Ramsey Medical Center (currently "Regions")

• Greater Minneapolis-St. Paul Area

• Medical Technologist

  • Aug 1980 - Aug 1987

  Biochemistry, Hematology, Blood Bank and Urinalysis Biochemistry, Hematology, Blood Bank and Urinalysis