Experience

Lifecore Biomedical

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director Information Technology Architecture

  • Jan 2023 - Present

  Responsible for strategic roadmap of application landscape. Currently leading the design stage of an ERP replacement project; interfacing with business SMEs and aligning their needs and goals with technical capabilities.

• Director Of Quality Control

  • Jun 2018 - Jan 2023

  Responsible for all laboratory operations. Development, validation, facility monitoring, and product testing at two sites. Led transition from paper-based to paperless lab via implementation of LabWare LIMS.

• Senior Manager of Quality

  • Jun 2016 - Jun 2018

  Management Representative / Head of Quality. Responsible for Quality Engineering/Validation, Quality Systems, Quality Assurance. Lifecore manufactures Class III medical devices, drug products, and combination products for US and OUS markets. Implemented visual management systems, developed KPIs, focused on improving training and putting Quality personnel at critical control points to minimize risk and maximize opportunities for improvement.

• Quality Control Manager

  • Sep 2015 - Jun 2016

  Responsible for Microbiology, Chemistry, Stability, and Validation functional groups. The QC Lab at Lifecore performs in-process, release, and stability testing for clinical and marketed medical devices and drug products.

• Analytical Development Manager

  • Jun 2013 - Sep 2015

  Oversaw analytical tech transfer for five new commercial products, including small-molecules and biologics. Responsible for development and validation of analytical methods. Drafted analytical CMC sections of regulatory documents (DMF, NDA, PMA, CEP). Authored, developed, and implemented a self-grown, full-featured LIMS system to house Development data. The system reduced department overhead by 20%. Based on ASP.NET / MVC 5 / Entity Framework.

• Associate Scientist, Analytical

  • May 2012 - Jun 2013

• Development Associate II / Sr

  • Sep 2008 - May 2012



Genmab MN / PDL BioPharma

• QC Analyst, Analytical Technologies & Validation

  • Jan 2007 - Sep 2008

  Qualification and troubleshooting of ELISA and human cell-culture based assays (eg FACS Flow cytometry, functionality of monoclonal antibody products). Qualification and troubleshooting of ELISA and human cell-culture based assays (eg FACS Flow cytometry, functionality of monoclonal antibody products).



PDL BioPharma

• Biotechnology Research
• 200 - 300 Employee

• QC Analyst, Microbiology/Tissue Culture

  • Jan 2005 - Dec 2006

  Routine microbiological testing. Investigations for OOS/OOL, Deviation/Non-conformance support. Developed and validated new cell culture technologies. Maintained human T-cell cultures. Routine microbiological testing. Investigations for OOS/OOL, Deviation/Non-conformance support. Developed and validated new cell culture technologies. Maintained human T-cell cultures.



University of Wisconsin-River Falls

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Student Assisant

  • Jan 2001 - Dec 2004

  Development and optimization of a Cellular Biology project robust enough for student laboratory use. Transformation of E.coli with GFP plasmid, plasmid isolation, gene isolation, protein expression and purification. Maintenance of microbiological cultures for Microbiology and Plant Pathology. Conducted USDA-grant funded research on tri-nucleotide SSRs for identification of soybean cultivars with Dr. Brad Mogen.

• Student Support Services Tutor

  • 2002 - 2004

  Employed as a student tutor by UWRF Student Support Services. Tutored Biology and Chemistry courses.



University of Minnesota

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant

  • May 2003 - Aug 2003

  Cereal grain disease resistance research with Dr. Brian Steffenson. Cereal grain disease resistance research with Dr. Brian Steffenson.