Cody Smith
*************@*****.***
PROFESSIONAL SUMMARY
Passionate scientist with over 9 years of experience in pharmaceutical, biotech, and life science industries, specializing in oligonucleotide synthesis, sterile pharmaceutical manufacturing, and analytical chemistry. Proven ability to independently design and execute experiments, troubleshoot complex analytical and process challenges, and support technology transfer from development to manufacturing. Skilled in HPLC method development, data interpretation, and scientific oral and written reporting. Eager to contribute to a team format through hands-on experience and analytical insight.
EXPERIENCE
TERA-print, Skokie - Scientist
December 2022 - Present
● Served as technical lead on cross-functional product development initiatives for novel biologic gene synthesis platforms
● Designed and implemented robust high-throughput protocols with manufacturability and scalability in mind
● Collaborated with cross-functional teams including hardware/software engineers to troubleshoot fluidics systems and optimize analytical workflows
● Prepared data summaries, technical reports, and scientific presentations to support internal R&D and grant funding proposals
● Generated sales leads and performed outwardly facing client relations for R&D projects pertaining to potential instrument purchases
Exicure, Chicago - Research Associate II
October 2019 - October 2022
● Performed column based DNA synthesis of nucleic acid therapeutics, ensuring accuracy and compliance with internal specifications and standards
● Designed and validated HPLC-based analytical methods for oligonucleotide purification used in early-phase biologics development
● Supported formulation stability studies, in-use evaluations, and drug product characterization
● Maintained meticulous laboratory records and authored technical reports to support product development milestones
● Designed protocols and ran automated processes using a Beckman Coulter i5 liquid handler
Dental Technologies Inc., Lincolnwood - Quality Assurance Supervisor January 2019 - October 2019
● Directed QA activities and managed a team overseeing manufacturing operations including batch record review and GMP compliance
● Led internal audits, managed FDA inspection preparedness, and resolved non-conformances through structured CAPA programs
● Participated in cross-departmental meetings to represent QA in design and manufacturing discussions
Fresenius Kabi, Melrose Park - Compounding Chemist August 2016 - July 2018
● Performed sterile compounding of injectable drug products in ISO-classified environments under FDA, GDP, and cGMP guidelines
● Supported batch formulation, raw material management, and cleanroom validations.
● Collaborated with Technology Transfer teams to scale up formulations and processes for large-batch sterile drug production
● Maintained detailed batch records and collaborated with QA during documentation review and process troubleshooting
Northeastern Illinois University, Chicago - Information Center Manager October 2011 - December 2015
● Supervised data analysis team of ten employees, developed SOPs, and maintained audit trails for university-wide data systems.
● Utilized Excel and Access to monitor compliance, generate reports, and improve internal processes.
EDUCATION
Northeastern Illinois University - M.S. in Chemistry: Separation Science August 2018 - December 2020
Northeastern Illinois University - B.S. in Chemistry August 2010 - December 2015