Lauren Stainback has extensive technical skills in chemistry, chemical engineering, molecular biology, microbiology, and computer skills. She has experience with a wide range of laboratory techniques and analytical methods. She also has strong language skills in English and conversational Spanish and French. Lauren holds various licenses, certifications, and regulatory knowledge in areas such as GMP, GLP, ISO, FDA, EPA, DOT, and OSHA compliance.

1. 1/2014
Lauren Stainback - Technical Skills Summary
Chemistry: Chemical synthesis, chemical purification (i.e. work up, recrystallization,
distillation), solution preparation, titration, extraction, filtration, separation, simple & fractional
distillation, reflux, melting point & boiling point determination, solubility tests, refraction index
determination & BRIX, freezing point depression, TLC, liquid chromatography (LC) (i.e. reverse
phase, ion, & size exclusion), Gas Chromatography (GC) with various detectors (i.e. FID, ECD,
& MS), reflux, recrystallization, Spectroscopy (i.e. UV, visible, IR, NMR, FTIR), Mass
Spectrometry (i.e. ESI, Time-of-Flight, Quadrupole Ion Trap), Microscopy (i.e. fluorescence,
electron, polarized, & phase contrast)
Chemical Engineering & Engineering Operations: Chemical properties analysis, process
modeling & scaling, feasibility studies, equipment evaluations (i.e. pump selection, reactor
specifications, feed stock management, in process monitoring, impeller/agitation efficiency,
thermal properties, heat-transfer analysis & distillation column specifications), enteral
parenteral & percutaneous chemical manufacturing & material transfer processes (all
production levels, bench to pilot scale), chemical manufacturing process evaluations &
translation/transfer to industrial scale plant operations, off-line and on-line process systems,
lyophilization/cryodessication/freeze-drying, GCP/GLP/GMP (GxP) system management,
equipment selection, processes validation & controls, FDA GxP facility planning,
Environmental Health & Safety training & procedures including DOT Hazmat procedures,
auditing regulated food, chemical, biotech, and pharmaceutical manufacturing plants or
factories, ISO clean rooms (i.e. monitoring, design, continuous process improvement (i.e.
material transfer, personnel gowning, and air lock protocol design & validation)
Molecular Biology: DNA extraction (i.e. nDNA & mtDNA), plasmid DNA preparation,
restriction enzyme digests, PCR (i.e. real time), agarose gel electrophoresis, SDS-PAGE, cell
fractionation by differential centrifugation, preparation of cells for cryopreservation, plasmid
preparation, ligation & transformation, genomic DNA & total RNA extraction, site-directed
mutagenesis, DNA sequencing, microarray, protein purification, preparative column
chromatography, membrane filtration, dialysis, SDS-PAGE, Western blot, bacterial protein
expression, protein refolding, mammalian cell protein expression, ELISA,
immunohistochemical staining, monoclonal antibody production, purification & isotyping,
enzyme-antibody conjugation, mixed lymphocyte reaction, transfection, reporter assay, cell
counting (haemacytometer), fluorescent microscopy, cell cloning, cell proliferation assay,
cAMP assay, cell culture, flow cytometry, cell-cell fusion assay, viral-cell fusion assay,
infectivity assay & virus generation
Microbiology: Aseptic & sterile techniques, optical microscopy, bacterial staining, plating
methods (streak, spread, pour, replica), enumeration & identification of bacteria, use of
biological safety cabinets, media & buffer preparation, water sample analysis by membrane
filtration & MPN, food microbiology, diagnostic biochemical tests for enteric bacteria, use of
selective media, Staph latex slide agglutination test, serotyping, antibiotic assay (MIC), plaque
assay, asbestos & mold sampling, lab testing (TEM), and remediation
Computer Skills: Programming (BASIC, C++, Python), Microsoft (Word, Excel, Access, &
PowerPoint), Macintosh & PC platforms, AutoCAD, Adobe (Photoshop, Acrobat, & In Design),
QuickBooks (Mac, Windows & Cloud), Sigma Plot, ChemDraw, Pub Med, typing (50+
words/minute), Android, Open Source, Database Admin, IT Admin, CISCO Server Admin, SEO
Certification, Arduino, Asana, & Slack

2. 1/2014
Language Skills: English, Conversational Spanish, French (Grade K-6), Introductory
Mandarin Chinese
Licenses & Certifications: Valid Class C North Carolina Driver's License with an excellent
driving record, Current US Passport with International Travel Experience, Red Cross First Aid
& CPR, Food Safe, HAACP, ASQ Biomedical Auditor, Notary Public (Texas), US Department
of Transportation (DOT) Urine & Breath Alcohol Testing Instructor, Six Sigma Green Belt,
Phlebotomy, Medical Laboratory Technician
Regulatory Body of Knowledge: Compliance, Regulations & Auditing
US FDA GCP, GLP, & GMP
US FDA CFR Title 21 Parts 1 to 1499 (April 1, 2015)
ISO 9001 & ISO 17025 Certifications
AIHA American Industrial Hygiene Association
American Society of Crime Lab Directors ASCLD-LAB International
DEA & State Controlled Substance Permit & Compliance (All Schedules)
EPA Product Evaluation & Submission
EPA State Level Regulation & Certification – (LA) LDEQ, (TX) TCEQ, (OK) OKDEQ, (FL)
FDEQ, (NC) NCDEQ, & others.
EH&S Health & Safety Compliance including DOT, OSHA & HazMat Certification
DOT Urine & Alcohol Sample Collection & Testing Programs
Proficiency, Method Validation, Methods of Analysis: AIHA, AOAC, FDA CFR 21 and FDA
BAM, EPA, ICH, NIOSH, NSF, OSHA & more upon request