- Gregg Sotack has over 25 years of experience in analytical chemistry and regulatory compliance. He has extensive experience with chromatography techniques like HPLC and GC, as well as other analytical methods. - Sotack has worked in both GLP and GMP environments developing and validating analytical methods for applications in research, quality control, and manufacturing. - He has a strong background in regulatory compliance including GLP, RCRA, OSHA, and some experience with GMP. Sotack has experience managing analytical laboratories and supervising other chemists.

1. GREGG S. SOTACK
A HIGHLY-EXPERIENCED ANALYTICAL CHEMIST & REGULATORY COMPLIANCE EXPERT
http://www.linkedin.com/in/greggsotack gregg_sotack@live.com (919) 417-1917
SUMMARY OF TECHNICAL COMPETENCIES:
 Chromatography: 25+ years experience with : HPLC, Gas Chromatography (GC), UPLC method
development, optimization, validation, transfer and sample analysis. Some experience with : GC-Mass
Spectrometry (GC-MS), Ion Exchange Chromatography (IC), Chiral HPLC, Size Exclusion (SEC) and
Gel Permeation / Gel Filtration Chromatography (GPC / GFC).
 Other techniques: 5+ years experience: Karl Fischer titration, UV-VIS spectroscopy, solid-phase
extraction. Some experience with : Evaporative Light-Scattering detection (ELSD), X-Ray Fluorescence
(XRF), NMR, Thermogravimetric analysis (TGA).
 Additional Specialties: Proper representative sampling techniques from heterogeneous bulk material,
analytical bias-control techniques, instrumentation IQ/OQ/PQ & calibration.
 Software: Agilent ChemStation® & OpenLab®, Perkin Elmer Turbochrom®, MS Word®, Excel® &
PowerPoint®, Lotus Notes®, Adobe Acrobat®, and Linux LibreOffice Writer®.
 Regulatory: GLP1
compliance, RCRA2
and OSHA compliance, HAZWOPER3
HAZMAT response, and
some GMP4
compliance (all in context of an R&D laboratory).
 GLP Study Types: Study Director and analyst for: 2-year storage stability / corrosion of commercial
product, analytical method validation, tank mix stability & uniformity, active ingredient content
certification, octanol-water coefficient, and pesticide residue in plant & animal tissue or in crop process
fractions.
 R&D5
Study Types: Analytical method development for (and analysis of) : samples for formulation
feasibility, batch uniformity, product cross-contamination, stability of active ingredient in sunlight or
ambient light, accelerated storage stability, freeze / thaw, seed coating efficiency, impurity profiles, etc.
PROFESSIONAL SUMMARY:
 Served 20+ years experience in a GLP environment, ~1 year in a GMP environment.
 Have 25+ years experience performing HPLC & Gas Chromatography (GC) method development, GLP
method validation, method transfer & sample analysis.
 Performed numerous routine QC analyses for manufacturing.
 Spent 20+ years developing, validating, & transferring enforcement analytical methods (HPLC & GC).
 Developed, validated, & used many other analytical methods for R&D applications.
 Developed a procedure for accurate & comprehensive analytical bias control for GLP & R&D analyses.
 Managed all aspects of operating an analytical standards repository in strict compliance with GLP &
RCRA.
 Wrote or revised numerous SOPs and Safe Work Practices (SWPs).
 Served 15+ years as a HAZMAT team emergency responder (40 hour HAZWOPER training).
 Supervised up to 2 Associate Chemists.
1
GLP: Good Laboratory Practices (cGLP: current GLP).
2
RCRA: Resource Conservation & Recovery Act (regulations pertaining to laboratory chemical use & disposal).
3
HAZWOPER: Hazardous Waste Operations & Emergency Response (HAZMAT spill response).
4
GMP: Good Manufacturing Practices (for pharmaceutical production facilities).
5
R&D: Analytical support in the formulation development stage that has yet to be under the auspices of GLP regulations.
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2. GREGG S. SOTACK
A HIGHLY-EXPERIENCED ANALYTICAL CHEMIST & REGULATORY COMPLIANCE EXPERT
http://www.linkedin.com/in/greggsotack gregg_sotack@live.com (919) 417-1917
MAJOR ACCOMPLISHMENTS:
 Most GLP enforcement & QC methods developed required <12 minutes from injection-to-injection.
 Most R&D support methods developed required <5 minutes from injection-to-injection.
 Designed a 5-step analytical bias-control program.
 Updated a tank mix stability method so that, if a prototype tank mix is shown to be a) chemically stable,
and b) uniform in composition over 24 hours, several environmental-fate studies could be eliminated.
 Developed a method for extracting & analyzing petroleum distillates from soil that's simple, rapid,
reproducible and accurate down to 10 ppm.
 Was recognized by external RCRA & GLP auditors for exemplary labeling & organization of chemicals in
storage units, and for effective use of mobile phase recyclers.
 Entrusted with authoring or revising numerous SOPs and Safe Work Practices.
 Retooled procedures of the reference standards repository so that a) all containers were labeled in strict
compliance with GLP & RCRA requirements, b) storage conditions were appropriate for each compound,
c) two containers of every batch were always available, d) the material (and shipping & receiving
documents) passed thru a single point-of-entry (with backup), e) annual audits checking the supply,
condition, compliance & expiry of each container were performed.
EMPLOYMENT HISTORY:
Agricultural Research Chemist; BASF Corporation; Research Triangle Park, NC.......June 1990 – October 2011
 Research Chemist I (Residue).................................................Residue – Plant/Animal (1990 – 1994)
 Research Chemist II (Formulation)............................................Biology/Formulations (1994 – 1998)
 Research Chemist III (Analytics)......................Formulation Development / Analytics (1999 – 2011)
Senior Chemist; Microbac (formerly Southern Testing & Research); Wilson, NC........January 1989 – June 1990
 Performed environmental, residue, agrochemical, and petroleum-spill analyses.
EDUCATION:
 M.S. Analytical Chemistry
6
; Virginia Tech, Blacksburg, VA
 B.S. Chemistry
7
; Virginia Tech, Blacksburg, VA
CERTIFICATIONS & TRAINING:
 40-Hour HAZMAT Spill Responder; Clyde Strong & Associates, College Station, TX
ACTIVITIES SINCE OCTOBER 2011:
 Cared for an acutely ill daughter (who has since recovered).
 Operated a small metals-recycling operation in cooperation with some local businesses.
 Worked part-time with Bayer Crop Science as a "Weekend Warrior": an in-store sales & technical
consultant promoting Bayer Advanced products.
 Independent study of the Good Manufacturing Practices and 21 CFR GLP regulations as they apply to
research, characterization, or QC laboratories or to a QAU auditor.
6
Graduate Research Director: Dr. Harold M. McNair
7
Undergraduate Research Director: Dr. Tomas Hudlicky
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