Experience

Eurofins Viracor BioPharma Services

• United States
• Biotechnology Research
• 1 - 100 Employee

• BioPharma Technical Writer and QC Review Supervisor

  • Nov 2022 - Present

  Lenexa, Kansas, United States

• Research Technical Writer Supervisor/Molecular Validation Scientific Coordinator

  • Apr 2021 - Nov 2022

  Lenexa, Kansas, United States

• Research Technical Writer

  • Jul 2020 - Apr 2021



KindredBio

• Manager, Assay Development

  • Feb 2020 - Jun 2020

  Elwood, KS

• Bioanalytical Scientist

  • Sep 2018 - Feb 2020

  Elwood, KS • Stability Program Manager – built the stability program from the ground up • Formulation Development for new biologicals • Compliance officer for QC department including SOP generation, LIMS development, waste disposal, preparation of Certificates of Analysis • Superuser for analytical equipment, including validation activities • QC team lead for all USDA-regulated projects • Managed employee workloads, interfacing with project managers • Lab coordination • Assay… Show more • Stability Program Manager – built the stability program from the ground up • Formulation Development for new biologicals • Compliance officer for QC department including SOP generation, LIMS development, waste disposal, preparation of Certificates of Analysis • Superuser for analytical equipment, including validation activities • QC team lead for all USDA-regulated projects • Managed employee workloads, interfacing with project managers • Lab coordination • Assay Development and Validation • Worked under GMP, GLP, and GCP regulations under 21CFR Part 58, 9CFR part 112 and 113, 21CFR Part 210 and Part 211



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate

  • Jun 2002 - Oct 2015

  De Soto, Kansas • Built, maintain, and administer Sharepoint site to track all R&D SOP documents, forms, and Softmax reader templates • Resource person for Softmax questions • Responsible for maintenance and upkeep of plate washers and HPLC units • Set up and administer sterility testing for R&D vaccines • Development and validation of ELISA potency methods, including antibody preparation and verification; SDS-PAGE and Western blotting for reagent verification • Supervising laboratory activities… Show more • Built, maintain, and administer Sharepoint site to track all R&D SOP documents, forms, and Softmax reader templates • Resource person for Softmax questions • Responsible for maintenance and upkeep of plate washers and HPLC units • Set up and administer sterility testing for R&D vaccines • Development and validation of ELISA potency methods, including antibody preparation and verification; SDS-PAGE and Western blotting for reagent verification • Supervising laboratory activities and small projects • Troubleshooting and revising existing assays; reference requalification • Primary investigator for animal studies; efficacy and duration of immunity • Training of entry-level technicians on ELISA, immunochemical, sterility, and protein assay techniques • Assisting with priority responses to USDA comments • Writing Study Protocols, and Study Reports • Culture, isolation, and identification of bacterial cells; culture of hybridoma and mammalian cells • Animal studies utilizing rabbits, mice, cows, horses, and swine Show less



MRIGlobal

• United States
• Research Services
• 200 - 300 Employee

• Staff Scientist

  • Aug 1996 - May 2002

  Kansas City, MO Staff Scientist, July 2000 – May 2002 • Project coordinator for a 3-year clinical study involving both employees and 2 sub-contractors; task leader for a multi-phase clinical study • Task leader for a 5-year study, supervised chemistry analysis task • Writing reports and scientific publications • Worked under GCP (Good Clinical Practice) and GLP regulations Associate Scientist, May 1998 – July 2000 • Operated the behavioral immunology laboratory using techniques such as… Show more Staff Scientist, July 2000 – May 2002 • Project coordinator for a 3-year clinical study involving both employees and 2 sub-contractors; task leader for a multi-phase clinical study • Task leader for a 5-year study, supervised chemistry analysis task • Writing reports and scientific publications • Worked under GCP (Good Clinical Practice) and GLP regulations Associate Scientist, May 1998 – July 2000 • Operated the behavioral immunology laboratory using techniques such as phlebotomy, radioimmunoassay, ELISA, and enzyme assays • Authorized user on NRC license • Coordinated and performed sample acquisition and testing from clinical study volunteers • Worked under GCP and GLP regulations; performed Peer review Associate Chemist, December 1996 – May 1998 • HPLC, GC, IC, CE, and wet chemical analysis of samples • Method development and validation • Generation and review of SOPs and reports • Chromatography committee member • Assumed project leadership during the medical leave of the study director, including all client contacts and a major data audit by one client • Worked under GLP and cGMP regulations; performed Peer review Show less



University of Kansas Medical Center

• Higher Education
• 700 & Above Employee

• Research Assistant in Infectious Diseases for the OB/GYN department

  • Oct 1995 - Aug 1996

  Kansas City, Missouri Area • Operated the infectious diseases laboratory, assayed both clinical and research samples • Assisted with planning and was responsible for implementation of research projects



Sanofi Animal Health (Rhone-Merieux, Inc)

• Research Technician

  • Jun 1995 - Oct 1995

  Lenexa, KS • Developed and performed ELISA screening, potency, and titration assays • Tissue culture of mammalian cells, bacterial fermentation • SDS-PAGE and Western blotting • Animal studies utilizing cows and swine • HPLC maintenance



Oread Laboratories

• Technician III

  • Oct 1992 - Jun 1994

  Lawrence, Kansas Area • HPLC, spectrophotometric, and gravimetric analysis of samples • Peer review in notebooks and reports • Worked under GLP and cGMP regulations • Safety and Health/Wellness committee member



Sterling Winthrop Pharmaceuticals

• Chemist I - Quality Control

  • Dec 1991 - Oct 1992

  McPherson, KS • Assayed raw materials, bulk preparations, finished product, and stability samples of parenteral pharmaceuticals using HPLC and wet chemistry methods • Responsible for all testing of samples from third party clients • Safety committee member • Worked under GLP and cGMP regulations