CHAD E. REESE
Morgantown,USA
Summary
Dynamic leader with extensive experience in laboratory operations and compliance at Green Analytics, LLC, TherapeuticsMD, and Mylan. Proven track record in analytical techniques, including HPLC and GC, while fostering collaboration and innovation. Successfully directed the launch of multiple cannabis testing labs, enhancing regulatory compliance and operational efficiency. Strong project management and team mentorship skills drive exceptional results.
Overview
28
28
years of professional experience
Work History
Director of Laboratory Operations and Compliance
Green Analytics, LLC (formerly Steep Hill)
Bridgeport, West Virginia
07.2021 - Current
- Oversaw construction and launch of cannabis testing laboratories in New Jersey, Maryland, and West Virginia.
- Collaborated with growers to validate, test, and report data for multiple dosage form products.
- Directed daily laboratory operations, ensuring compliance and high testing throughput.
- Established procedures to enhance regulatory compliance within the laboratory.
Vice President of Laboratory Operations for the East Region
ACT Laboratories
Lansing, MI
10.2020 - 06.2021
- Oversaw operations of three analytical chemistry testing labs within Cannabis Testing in eastern region.
- Collaborated with growers to develop, validate, test, and report data for multiple dosage forms.
- Managed expansion efforts at two facilities and initiated startup of a third laboratory.
- Established procedures to ensure compliance and maintain quality data across ACT Laboratories network.
Director, Analytical Chemistry in Research and Development and Quality Control
THERAPEUTICSMD
Boca Raton, FL
05.2018 - 10.2020
- Oversaw the R&D analytical chemistry department and QC department for a virtual pharmaceutical company specializing in women’s healthcare.
- Worked with contract manufacturers and laboratories to develop, validate, test and report data from preclinical through commercial products nationally and internationally.
- Managed Phase 1 IND development and submission for protection of current commercial product and extension of the product pipeline.
- Actively managed and authored multiple FDA comment responses and post marketing commitments to ensure product approval with no delays in the commercial product supply.
- Project lead for a project to add an alternate manufacturing site and API vendor.
- Supervised a team of scientists supporting R&D and QC.
Consultant
INDEPENDENT CONSULTANT
Morgantown, WV
02.2018 - 05.2018
- Consulted on projects in pharmaceutical and medical device markets.
- Provided expertise to Catalent Pharma Solutions as a contract consultant.
- Advised Guidepoint on topical pharmaceutical formulation and chemical markets.
- Evaluated regulatory and quality aspects for Novosource LLC in medical device industry.
Director, Quality Control Raw Materials
MYLAN PHARMACEUTICALS
Morgantown, WV
01.2017 - 10.2017
- Managed release testing for active ingredients, inactive ingredients, and packaging supplies in quality control laboratory.
- Oversaw operations of HPLC, GC, wet chemistry groups, cleaning validation team, and drug stock room with over 75 employees.
- Directed departmental responsibilities concerning laboratory equipment, staffing, investigations, regulatory compliance, and vendor selection.
Director
MYLAN TECHNOLOGIES
Morgantown, WV
03.2016 - 01.2017
- Directed Analytical Chemistry Department of 10 employees supporting NDA and ANDA dermal products development.
- Oversaw laboratory equipment, staffing, LIMS, Trackwise, and regulatory compliance activities.
- Managed method development, validation, and transfers to ensure quality standards.
- Executed Technical Services function for topical products to enhance research outcomes.
Senior Lead Scientist
MYLAN TECHNOLOGIES
Morgantown, WV
03.2013 - 03.2016
- Led Analytical Chemistry group for Transdermal Products Research and Development.
- Mentored up to 12 scientists to develop robust testing methods and ensure product quality.
- Developed Quality Management Systems for new pilot plant production facility.
- Oversaw departmental meetings and project development, consistently exceeding timelines.
- Coordinated analytical activities and method transfers across multiple company locations.
- Created submission documents and responses to regulatory agencies worldwide.
Lead Scientist
MYLAN TECHNOLOGIES
Morgantown, WV
03.2011 - 03.2013
- Directed team of scientists and chemists in developing and validating methods for transdermal products.
- Supported formulation efforts for transdermal patches, creams, gels, ointments, and thin film oral products.
- Facilitated method transfer and process development to ensure successful scale-up and commercialization.
Senior Formulation Scientist
MYLAN PHARMACEUTICALS
Morgantown, WV
04.2007 - 02.2011
- Developed manufacturing processes for oral dosage forms, optimizing immediate and modified release profiles.
- Coordinated scale-up and launch activities across Morgantown and Puerto Rico, ensuring seamless transitions.
- Managed projects from pre-formulation through commercialization, meeting key milestones effectively.
- Reviewed patents to develop non-infringing formulations, with paragraph IV filings FDA-approved.
- Authored ANDA submissions and responses to comment letters, maintaining regulatory compliance.
- Drafted documentation including executive summaries, validation protocols, and master batch records.
- Conducted IQ/OQ/PQ on new equipment, ensuring operational readiness and compliance.
- Trained and mentored scientists and technicians to enhance team capability.
Scientist
MYLAN PHARMACEUTICALS
Morgantown, WV
02.2003 - 04.2007
- Developed analytical testing methods for ANDA Solid Oral Dosage Form Pharmaceuticals.
- Assembled comprehensive documents for ANDA applications to ensure regulatory compliance.
- Assisted product development from conception to ANDA submission for generic drug candidates.
- Established drug substance and product specifications per FDA and ICH guidelines.
- Evaluated API vendors, characterized drug substances, and set stability specifications for drug products.
- Released raw materials and drug products for clinical trials while approving validation processes.
- Served as analytical representative in product team meetings, addressing FDA correspondence.
- Trained and mentored scientists and chemists, fostering professional growth and knowledge transfer.
Graduate Research Assistant
UNIVERSITY OF PITTSBURGH
Pittsburgh, Pennsylvania
08.1998 - 02.2003
- Created colloidal syntheses for monodisperse, highly charged particles.
- Engineered colorimetric reagent and optrode sensors for Pb2+ detection in bodily fluids.
- Designed an optical limiter utilizing photonic crystals.
Intern
CERDEC CORPORATION (currently Ferro Corp.)
Washington, PA
02.1998 - 08.1998
- Utilized AA spectroscopy to detect ion release from pigmented glass frit.
- Developed methodology and SOP for A2LA accreditation related to Pb2+.
- Established rigorous testing protocols to ensure compliance with industry standards.
Summer Intern
BAYER CORPORATION
Leverkusen, Germany
06.1997 - 08.1997
- Executed quality control assessments on polymer samples utilizing infrared spectroscopy..
Education
Ph.D. - Analytical Chemistry / Materials Science
University of Pittsburgh
Pittsburgh, PA02.2003
Bachelor of Arts - Chemistry (ACS Certified)
Washington and Jefferson College
Washington, PASkills
- Rheology and viscosity
- Shear and adhesion
- UHPLC and HPLC
- Analytical techniques: AA, AFM, DSC, FFF, GFAA, IR, NMR, TEM, TGA, UV-Vis, GC, HPLC-MS, SEM, ICP-MS, GC-MS
- Microbiological testing and LIMS
- SAP and Minitab proficiency
- Granulation techniques: fluid bed, wet, dry
- Roller compaction and extrusion
- Encapsulation and tableting
- Coating methods: functional and nonfunctional
- Osmotic pump technology
- Liquid filling of capsules
- Solid dispersions and suspensions
- Imprinting and packaging strategies
- Thin film dosage form development
- Soft polymer systems and nanoparticles
Presentations Seminars
- American Chemical Society Short Course on “Patent Law Fundamentals” Morgantown, WV. June 2011.
- Colorcon Seminar on “Colorcon Coating School” Morgantown, WV. December 2007.
- Glatt Air Techniques, Inc. seminar on “Current Practices in Solid Dosage Form Processing” Ramsey, NJ. May 2007.
- AAPS 2006, San Antonio, Texas (Oct 29-Nov 2).
- Varian Seminar on Dissolution and Bioequivalence of Drugs, Cary, NC. June 2004.
- Reese, C.E.; Asher, S.A. “Crystalline Colloidal Self Assembly: A Motif for Fabricating Smart Materials and Chemical Sensing Devices” 30th Annual Meeting of the American Society for Photobiology, Quebec City, Canada, July 2002; Paper 224.
- Reese, C.E.; Asher, S.A. “Development of an Intelligent Polymerized Crystalline Colloidal Array Colorimetric Reagent” Pittsburgh Conference on Analytical Chemistry, New Orleans, LA, March 2002; Paper 1270.
- Reese, C.E., Asher, S.A. “Crystalline Colloidal Self Assembly: A Motif for Creating Smart Materials for Chemical Sensing and Electro-optics” UK Polymer Colloids Forum, Guildford, Surrey, April 2001.
Websites
Patents Publications
- Mikhonin, A.V.; Maurer, M.K.; Reese, C.E.; Asher, S.A. Simple nanosecond to minutes transient absorption spectrophotometer. Applied Spectros. 2005 59(12), 1534-1540.
- Reese C.E.; Mikhonin A.V.; Kamenjicki M; Tikhonov A.; Asher S.A. Nanogel nanosecond photonic crystal optical switching. J Am Chem Soc. 2004 126(5), 1493-1496.
- Asher, S.A.; Reese, C.E. Polymerized Crystalline Colloidal Array Chemical Sensing Materials for use in High Ionic Strength Solutions. U.S. Patent 6,753,191 B2, 2004.
- Reese, C.E.; Asher, S. A. Photonic crystal optrode sensor for detection of Pb2+ in high ionic strength environments. Anal Chem. 2003, 75, 3915-3918.
- Asher, S.A.; Peteu, S.F.; Reese, C.E.; Lin, M.; Finegold, D. Polymerized Crystalline Colloidal Array Chemical Sensing Materials for Detection of Lead in Bodily Fluids. Anal. Bioanal. Chem., 2002, 373, 632-638.
- Asher, S.A.; Reese, C.E. Colorimetric Reagent. U.S. Pat. Appl. Publ. 2002/0031841 A1, 2002.
- Reese, C.E.; Asher, S.A. Emulsifier-Free Emulsion Polymerization Produces Highly Charged, Monodisperse Particles for Near Infrared Photonic Crystals J. Colloid Interface Sci. 2002, 248(1), 41-46.
- Reese, C.E.; Baltusavich, M.E.; Keim, J.P.; Asher, S.A. Development of an Intelligent Polymerized Crystalline Colloidal Array Colorimetric Reagent. Anal. Chem. 2001, 73, 5038-5042
- Reese, C.E.; Guerrero, C.D.; Weissman, J.M.; Lee, K.; Asher, S.A. Synthesis of Highly Charged, Monodisperse Polystyrene Colloidal Particles for the Fabrication of Photonic Crystals. J. Colloid Interface Sci. 2000, 232(1), 76-80.
- Durig, J.R.; Drew, B.R.; Reese, C.E.; Brletic, P.A. Infrared and Raman Spectra, Conformational Stability, ab initio Calculations and Vibrational Assignments for trans-3-chloropropenoyl chloride. Spectrochim. Acta, Part A 2000, 56A, 2091-2106.
Key Qualifications
- Experience Supervising multiple laboratories in the Pharmaceutical and Cannabis industry.
- Numerous US and non-US submissions in formulation and analytical research and development.
- Project lead for multiple regulatory submissions including NDA and ANDA submissions with several Paragraph IV First to File opportunities.
- FDA teleconference and comment letter response writing experience.
- Experience with Contract Manufacturing and Laboratories.
- Lean Six Sigma Black Belt Certified.
- Developed Quality Management Systems for new pilot plant production facility.
- Experience with Rheology, Shear, Adhesion, Viscosity, Tack, uHPLC, HPLC, AA, AFM, DSC, FFF, GFAA, IR, NMR, TEM, TGA, UV-Vis, GC, HPLC-MS, SEM, ICP-MS, GC-MS, microbiological testing and numerous computer applications including LIMS, SAP and Minitab.
- Experience with fluid bed granulation techniques, roller compaction, extrusion/spheronization, high and low shear mixers, wet and dry granulation, direct compression, encapsulation, tableting, functional and nonfunctional coating, osmotic pump technology, liquid filling of capsules with banding, solid dispersions, suspensions, imprinting, packaging and thin film dosage form development.
- Working knowledge of soft polymer material systems, nanoparticles, colloids, chemical sensors, thin films and photonic crystals.
Timeline
Director of Laboratory Operations and Compliance
Green Analytics, LLC (formerly Steep Hill)
07.2021 - Current
Vice President of Laboratory Operations for the East Region
ACT Laboratories
10.2020 - 06.2021
Director, Analytical Chemistry in Research and Development and Quality Control
THERAPEUTICSMD
05.2018 - 10.2020
Consultant
INDEPENDENT CONSULTANT
02.2018 - 05.2018
Director, Quality Control Raw Materials
MYLAN PHARMACEUTICALS
01.2017 - 10.2017
Director
MYLAN TECHNOLOGIES
03.2016 - 01.2017
Senior Lead Scientist
MYLAN TECHNOLOGIES
03.2013 - 03.2016
Lead Scientist
MYLAN TECHNOLOGIES
03.2011 - 03.2013
Senior Formulation Scientist
MYLAN PHARMACEUTICALS
04.2007 - 02.2011
Scientist
MYLAN PHARMACEUTICALS
02.2003 - 04.2007
Graduate Research Assistant
UNIVERSITY OF PITTSBURGH
08.1998 - 02.2003
Intern
CERDEC CORPORATION (currently Ferro Corp.)
02.1998 - 08.1998
Summer Intern
BAYER CORPORATION
06.1997 - 08.1997
Ph.D. - Analytical Chemistry / Materials Science
University of Pittsburgh
Bachelor of Arts - Chemistry (ACS Certified)
Washington and Jefferson College