ABOUT
My Background
As a natural born go-getter, my passion has continuously driven me to expand my knowledge, experience, and relationships. With a strong background and diverse skill set, I’m confident in the creative ideas and successful solutions I bring to the table. Keep exploring my site to learn more information about me, and reach out directly with any questions.
MY EXPERIENCE
Purification and Cell Culture Specialist
Takeda Pharmaceuticals
February 2017 - Present
· Oversee Manufacturing Associates to assure they are working in a cGMP compliant and safe manner. Ensures adherence to the (daily) manufacturing schedule.
· Performs/ assists with Processing Steps and/or Manufacturing Support activities, monitoring process against the batch record, SLR and control system.
· Documents/Records cGMP data and information for processing steps and/or equipment activities, following standard operating procedures.
Key documentation includes batch records, SLRs, and equipment logbooks.
· Coordinate training and development of Manufacturing Associates.
· Reviews Manufacturing documentation on a daily basis (BPR’s, .LB’s etc.)
· Coordinate Facilities, Metrology, Validation, Product Development and other non-routine activities with the manufacturing schedule.
· Provide oversight of support groups when working with manufacturing systems
· Provide leadership support during trouble shooting of equipment, operation and processes
· Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives
· Leads/ supports deviation initiation, investigations and closure. Participates in cross functional project teams, supports technical transfers with relevant teams/ individuals.
Research Associate - Cell Culture Development
R&D Systems | Bio-Techne
September 2013-January 2017
· Supervised, reviewed and assisted the development of new SOPs and followed previously established SOPs to troubleshoot, maintain and operate large scale bioreactors for the production of monoclonal antibodies and proteins in CHO-S, HEK293 and NS0 mammalian expression systems.
· Supervised and assisted development of media and reagent testing for several mammalian cell lines including NS0, CHO-S, HEK293, Hybridomas and THP-1.
· Supervised, trained and assistedless experienced associates withoptimization experiments utilizing flow cytometry, ELISA, DNA electrophoresis, EMSA, protein microarrays, etc. for the development and process design for transiently expressed antibodies and proteins.
· Led development projects targeted at process optimization and technology transfer from pilot scaleto manufacturing of recombinant protein and antibody in stable and transient expression systems of CHO-S and HEK293 cells under a cGMP environment.
· Under cGMP maintained thorough documentation and batch run records, conducted auditing of run records and troubleshooting of equipment with newly hired or less experienced associates.
EDUCATION
University of Minnesota - Twin Cities
BS Chemistry, Minor Biochemistry
2011-May 2013
· Coursework in Analytical Chemistry, Advanced organic multi-step Synthesis, Inorganic Chemistry, Chemical Biology of Enzymes, Biochemistry, graduate course work in HTS and High-throughput drug discovery, etc.
· Formal training of H1,Cl35,C13 and N15-NMR sample preparation, obtaining 2-D and 3-D NMR spectra and basic 3-D sample analysis on a Bruker or Varian
· Formal training of a large array of chemistry and biochemistry laboratory equipment; GC/MS, HPLC, NMR, UV-Vis, IR, TLC, Magnetic susceptibility using a Gouy balance, etc.
Anoka-Ramsey Community College
Associates of Arts Degree
2009-2011
· Successful completion of Associate of Arts degree
· Strong emphasis in Chemistry, Biology and Physics courses
Coursework includes: General Chemistry I&II, Organic Chemistry I&II, Calculus I&II, General Biology, Cell Biology, and Calculus based Physics.
St. Cloud State University
Masters of Business Administration
August 2017 - August 2019
MY SKILLS
What I Do
Biologics Specialist
Strong knowledge of cGMP biologics pharmaceutical clinical development and commercial manufacturing. Specializing in Commissioning and Qualification, Validation, large scale bioreactor mammalian cell culture, harvest, purification, and drug bulk substance fill.
CFR Title 21 SME
Front line SME during FDA inspections. Comprehensive FDA Pre-Approval Inspection successful execution and support.
Problem Solver
A team player looking to brainstorm and find solutions to problems big and small. Successful startup of commercial pharmaceutical site, experienced problem solver in FDA, validation, process flow, automation, and start up activities.
