Donna Gustafson Email and Phone Number

Perform viral proliferation assay for vaccine characterization.Aid in the development of a staining protocol for mycoplasma.Provide guidance to junior coworkers on proper cGMP documentation for development experiments in electronic notebooks (ELN).Author technical communications, reports and protocols as necessary.Execute troubleshooting experiments to improve processes and procedures.Remain current with training for all company and client policies, SOPs, ASOPs, and safety.Carry out second scientist review of experimental notebooks, equipment usage logbooks and cleaning logs. Perform ELISA validation.

Contracted through Aerotek to work within the Molecular Biology testing group as a member of the Genetic Stability Group and became a permanent WuXi employee December 2015.Perform and direct assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs).Initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects.Execute Genetic Stability (GS) assays including Southern and Northern Blotting and copy number qPCR-related tests.Manage five direct reports.Train junior staff members on GS assays.Perform Research & Development activities.Carry out Study Director/Technical Reviewer functions for GS assays, including Southern Blots, qPCR copy number assays and ddPCR genome titer assays.Assist supervisor with day-to-day lab management duties.Update and communicate project progress with Project Management (PM), Account Management (AM) and Quality Assurance (QA) groups.Correctly analyze scientific data with accuracy and precision.Write and revise SOPs as needed.Remain current with trainings for all company policies, SOPs, test methods, safety and compliance.

Set up QIAGEN BioRobot MDx workstations to extract and purify DNA from clinical trial swab and thin section samples.Used the TECAN Evo automated liquid handling instruments to add DNA to PCR plates containing real-time PCR primers and probes to test for the presence or absence of 14 different types of HPV.Used Stratagene Mx 3000P and 3005P real-time instruments to perform real-time PCR and analyzed the results using the MxPro software.Work within a high throughput group using a team approach to generate over 500,000 data points during a six month time span, while still meeting all client deadlines.Reviewed peer generated data for completeness and compliance with molecular testing SOPs.Acted as a liaison between Agilent and PPD to schedule repair and preventative maintenance for the 45 Stratagene Mx3000P and Mx3005P real-time instruments.Qualified new oligonucleotide and probe lots for clinical testing according to molecular testing SOPs.Manually extracted clinical trial specimen DNA from swabs, scrapings, and whole blood using QIAGEN kits.Designed and executed experiments for independent group approved research project.Completed experimental write-ups for independent group approved research project.Remained up to date on all SOP trainings.Revised and rewrote SOPs as needed.Participated in the Quality Committee whose mission is to improve site wide quality of projects, data generation and execution.Assisted with assay development for a new real-time PCR based influenza project.

Isolated RNA from rhabdomyosarcoma tumors to determine the tumor subtype via RT-PCR.Used Southern blot analysis to discover common amplicons in ARMS tumors.Finalized the protocol for an RT-PCR based minimal disease assay to detect circulating melanoma cells using patient blood.Extracted RNA from paraffin embedded samples and designed the realtime RT-PCR assay to subtype the ARMS tumors.Utilized microarray technologies and bioinformatics software to localize ARMS tumor amplicons.Performed qRT-PCR analysis for coding genes and microRNAs within amplicons of interest.Organized the data and gathered it into spreadsheets to be sent to our collaborators.Studied the biology of cell lines through retroviral gene delivery, western blots, plating efficiency, focus formation, growth curves and cell proliferation assays.Tested cell lines response to a protease inhibitor.Developed and finalized the DNA methylation protocol to complete a pilot study that was further funded.Functioned as the lab manager, handled ordering, grant spending, and trained new employees as needed.Maintained lab notebooks and clear lines of communication with my supervisor.

Extracted and quantified cell line DNA.Performed quality control assays to assess DNA integrity including diagnostic digests and protein quantification.Subtyped samples for gender and tested for mycoplasma contamination using PCR.Investigated familial relationships by Southern blot analysis and microsatellite comparisons.Characterized hybrid cell lines by resolving PCR products on acrylamide gels.Maintained isotope notebooks.

Learned general laboratory skills and set up biology labs.Washed glassware and prepared microbiology medium.Supervised work study students in the absence of the lab manager.Undergraduate Senior Research Project:Do RAPD Markers Follow Mendelian Genetics in Panicum miliaceum

Assisted the research scientist in setting up rapid preps to study the DNA of Escherichia coli. Screened colonies for correct orientation of constructs.Ran agarose gels to verify the orientation of DNA.