Ryan D. Smith, RAC

Columbia, SC *****

803-***-**** – ad32ck@r.postjobfree.com

Professional Summary

Deadline driven Analytical Chemist demonstrating superior quality assurance and accuracy in recording results. Astute professional with exceptional usage of analytical techniques, including high pressure and ultra-high pressure liquid chromatography. Also experienced with drafting documents in the common technical document format for regulatory submission. Striving to open new doors in career path in the analytical sciences field.

Skills

Results interpretation • Record keeping requirements

Chemical compound examination • MRP and ERP systems

Specification development • Method development and validation

Testing oversight and management • Leadership and mentorship

Work History

03/2015 to Current Analytical Chemist III

The Ritedose Corporation – Columbia, SC

Responsible of testing, release, and compendial method verification for analytical characterization methods for all raw materials that meet ICH and regulatory body guidelines and requirements.

Provide leadership, guidance, and mentorship to senior and junior analytical chemists on multiple projects that I am the subject matter expert on.

Drafting of raw material specifications that meet ICH guidelines as well as justification of specification supporting documents to be submitted to appropriate regulatory body for ANDA and NDA submission.

Assist in post approval submissions that include use of alternate API supplier and optimized methods that occurred after initial submission.

Responsible for analytical development, screening and optimization of analytical characterization methods that meet ICH guidelines for new drug products, drug substances and excipients. Methods including potency by HPLC/UPLC, identification by infrared spectroscopy, UV/Vis spectroscopy, zeta potential, particle size distribution, and elemental impurities by mass spectroscopy.

Responsible for drafting and execution of method validation protocols for analytical characterization methods that meet ICH and regulatory body guidelines and requirements.

Responsible for drafting deviations and investigations for drug product, drug substances and excipients that determine a valid root cause, or proceed to the drafting and implantation of associated CAPA’s.

Duties include assisting product development engineers with formulation development, analysis of developmental, clinical and registration batches at in-process, release, and stability time points.

Draft specifications and analytical test methods for assigned products that meet appropriate ICH and regulatory requirements.

Draft investigations to address any deviations or out of specifications that may arise during testing and formulation of the product.

Assist Regulatory Affairs with drafting and review of ANDA and NDA submissions in the Common Technical Document format specifically section 3 of the drug product filing.

02/2011 to 03/2015 QC Chemist I

Qualitest Pharmaceutical – Charlotte, NC

Responsible for testing of finished products lots by HPLC, wet chemistry, IR, and UV.

Standard coordinator: responsible for issuing new control, and non-control standards to chemists.

Assisted in troubleshooting HPLC systems and repaired them. Received additional training from Waters on performance maintenance on alliance and component based HPLC system.

Assigned daily duties and projects to other chemists, and provided oversight to ensure that projects were completed in a timely manner, or provided update to other shifts so work could be passed over.

Assigned to handle all technical troubleshooting of HPLC/UPLC equipment by the metrology department, and provided technical assistance or performed necessary repairs for other chemists.

08/2009 to 09/2010 QC Chemist

Perrigo – Greenville, SC

Tested raw material for release to be used in manufacturing of nutraceuticals for commercial release.

Assisted the Research and Development team in new product formulations.

Assisted method development team in development of more robust and precise analytical method for the assay of Vitamin D content in finished product goods.

08/2008 to 08/2009 Research Associate

Clemson University – Clemson, SC

Assisted Dr. Chita Kole in research of hyperglycemic properties of M. charantia.

Performed DNA extraction of 23 varieties of M. charantia and DNA characterization by restriction endonucleases.

12/2007 – 08/2008 Assistant Lab Coordinator and Adjunct Faculty

Tri-County Technical College – Pendleton, SC

Set up all labs for life sciences courses offered at Tri-County Technical College.

Assisted in grading of tests and written essay for life science courses at Tri-County Technical College.

Taught Anatomy and Physiology 101 lab for students enrolled in nursing program.

Education

Masters of Science of Drug Development

University of Cincinnati

August 2022 – April 2024

Cumulative GPA 3.9 on 4.0 scale

Curriculum is a collaboration between academia, industry, and government agencies to provide a cross disciplinary training of the drug development process.

Bachelor of Science Biological Sciences

Clemson University

Assisted in research of M. charantia (bitter melons) for hyperglycemic properties found in 23 different varieties.

Worked part time from sophomore year through senior year as both a pharmaceutical technician and research assistant at botanical gardens.

Diploma

Airport High School

Academic letterman

Member of B-27 club (all A’s and B’s for academic year)

Certifications

RAC Drugs

Certified [RAC Drugs] [Regulatory Affairs Professional Society] – [April 2021]

Global Regulatory Affairs Certificate

Certified [University of Cincinnati] – [January 2024]

Clinical Trial Design and Research Certificate

Certified [University of Cincinnati] – [January 2024]

HAZWOPER

Certified hazardous material technician [February 2012 – February 2015]

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