Experience

Grand River Aseptic Manufacturing

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• • Jan 2022 - Present

  Lead a team of four scientists in the development and validation of new analytical test methods for testing raw materials, active pharmaceutical ingredients (API) and finished products. Provide leadership and guidance to the analytical services team. Review and approve analytical documentation and procedures including material specifications, test methods, validation protocols, reports, standard operating procedures, and client work orders. Perform analytical project leader duties for clients. Train chemists in the necessary skills to be successful in their position. Operate under cGMP procedures. Perform cGMP analytical data review Show less

• • Oct 2020 - Dec 2021

  Developed and validated new analytical methods for testing raw materials, active pharmaceutical ingredients (API) and finished products. Performed analytical project leader duties including providing project updates, evaluation of project timelines, and general correspondence with clients. Revised SOPs in accordance with pharmacopoeia and FDA guidance. Trained chemists in the necessary analytical skills to be successful in their position. Operated under cGMP procedures. Performed cGMP analytical data review. Show less



Hydrite

• United States
• Chemical Manufacturing
• 500 - 600 Employee

• Senior Analytical Chemist

  • Apr 2019 - Oct 2020

  Developed new analytical methods for testing raw materials, lab formulas, and finished products. Provided analytical support to various business units including Quality Control. Generated and revised analytical instrumentation SOPs. Conducted instrumentation qualification, maintenance, and repair. Developed new analytical methods for testing raw materials, lab formulas, and finished products. Provided analytical support to various business units including Quality Control. Generated and revised analytical instrumentation SOPs. Conducted instrumentation qualification, maintenance, and repair.



Curia

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Scientist - Analytical

  • Apr 2017 - Apr 2019

  Developed and validated new analytical methods for testing raw materials, in-process samples, and active pharmaceutical ingredients (API). Performed analytical project leader duties including providing project updates, evaluation of project timelines, and general correspondence with clients. Revised SOPs in accordance with USP/FDA guidance. Conducted instrumentation qualification, maintenance, and repair. Trained chemists in the necessary analytical skills to be successful in their position. Handled high potency APIs. Operated under cGMP procedures. Performed cGMP analytical data review. Show less



Alcami Corporation

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• AR&D Scientist III

  • Aug 2016 - Apr 2017

  Developed and validated new analytical methods for testing raw materials, in-process samples, and active pharmaceutical ingredients (API). Participated in the drafting and execution of method transfers and validation protocols and reports. Revised SOPs in accordance with USP/FDA guidance. Operated under cGMP procedures. Conducted instrumentation troubleshooting. Developed and validated new analytical methods for testing raw materials, in-process samples, and active pharmaceutical ingredients (API). Participated in the drafting and execution of method transfers and validation protocols and reports. Revised SOPs in accordance with USP/FDA guidance. Operated under cGMP procedures. Conducted instrumentation troubleshooting.



Pegasus Laboratories, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Analytical Instrumentation and Materials Specialist

  • Aug 2015 - Apr 2016

  Wrote and executed qualification (IQ/OQ/PQ) protocols and reports for laboratory equipment. Performed routine maintenance and qualification of laboratory instrumentation. Provided technical support for the evaluation and qualification of raw materials for commercial use. Developed and validated analytical methods for raw materials (API and excipients) per FDA/ICH/USP guidelines. Wrote and executed method validation protocols and reports. Coordinated analytical method transfer between technical services and quality control. Maintained raw material testing in accordance with USP standards. Trained quality control personnel on new laboratory equipment. Trained chemists the necessary analytical skills to be successful in their position. Created and revised SOPs in accordance with FDA/ICH/USP guidance. Performed analytical data review. Show less



Patheon

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Scientist I

  • Mar 2014 - Aug 2015

  Managed the analytical method development and testing of raw materials to support phase II, III, and commercial active pharmaceutical ingredient (API) production under cGMP procedures. Developed new analytical methods for testing raw materials, in-process samples, and APIs. Managed two QC chemists for raw material testing. Drafted and executed method transfer and validation protocols and reports. Conducted instrumentation maintenance and repair in the QC/Analytical lab. Drafted detailed cGMP documentation such as out of specification (OOS) investigations, change controls, deviations, etc. Trained and mentored new chemists with the necessary analytical skills to be successful in their positions. Performed analytical data review. Show less