Samuel Harrell Email & Phone Number

Remote

Proven track record as an early team member in a start-up, driving the development of small molecule and peptide generic products across multiple dosage forms (tablets, injectables, inhalation). CMC submission authorship for US and EU markets experience. Experience in managing analytical development and quality control systems that supported commercial and pipeline assets. Successfully led cross-functional collaborations with global contract organizations. Executed critical studies to ensure product integrity. Demonstrated expertise in quality management, including CAPAs, audits, and deviation investigations, ensuring regulatory compliance and continuous product improvement.

Boulder, Co

Experienced in managing stability projects for clinical and commercial studies across 34 clients with over 100 active studies. Successfully harmonized SOPs across sites to streamline ICH stability reporting, reducing turnaround times. Qualified novel compounds for early-phase development, led OOS and OOT investigations to identify root causes, and supported 24/7 analytical projects for continuous manufacturing. Served as SME for HPLC, CAD, GC, and ICP-MS instrumentation, ensuring high standards in analytical support and operations.

Brevard, North Carolina

Led analytical R&D projects from scale-up to GMP production for small molecule APIs, including chiral method development on HPLC for novel compounds. Developed and validated GC and UPLC-CAD methods for reaction completion and API release, with expertise in XRPD, DSC, and TGA for oral formulation support. Skilled in impurity characterization and structure elucidation using LC-MS, GC-MS, and NMR.

Decatur, Illinois Area

My main work project was working on the implementation of USP <232> for Akorn's Decatur site. Over the course of a year, I helped lead a team through method development and validation for over 100 different products. The implementation of USP <232> has been very rewarding experience because of the amount of obstacles to success that we faced and overcame as a team.

West Lafayette

Franklin Indiana

Applied Energy Lab

While working at the Applied Energy Lab, I created technical drawings of HVAC and solar systems, I worked on the programming logic for an automated controller that was used in the Purdue Solar Decathlon 2011 InHome. Another main responsibility was working with the community and giving tours of the Purdue InHome to technical and nontechnical visitors. (The InHome was a intercollegiate competition with the goal of building an extremely affordable home that was as energy and environmentally friendly as possible. This project was powered by the DOE, and Purdue placed 2nd place!)