Experience

Ocular Therapeutix, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Control Supervisor

  • Jan 2021 - Present

  I am a member of the Quality Control group at a company that specializes in ophthalmic medical devices and drug delivery. My responsibilities include: - performing testing of finished product in support of stability and batch release.- troubleshooting analytical methods and instrumentation.- writing SOPs, test methods, validation protocols and reports, technical documents, deviations, and CAPAs.- leading OOS/OOT laboratory investigations.- supervising direct reports. - Developing, optimizing, validating, and transferring analytical methods. - training new hires.- reviewing laboratory notebooks and data. Previously worked as a member of Analytical Development. My activities included development, optimization, validation, and transfer of analytical methods for projects spanning Phase 1 to commercial. I also performed routine analytical testing to support process development, product development, and quality control activities on multiple projects.Responsibilities:- Supervised one direct report. - Developed, optimized, and validated analytical test methods.- Transferred methods from AD to QC. - Tested raw materials, in-process materials, drug substances, and finished drug products per cGMPs.- Performed routine testing in support of research, process development, product development, and scale-up.- Performed analysis on small molecule and protein-based formulations.- Managed outsourced testing. - Supervised and mentored interns. Training Attended:Maintaining ACQUITY UPLC Systems - May 26, 2017 - Waters Corporation, Milford, MASkills: HPLC/UPLC, UV-Vis, Karl Fischer, Laser Diffraction, Gas Chromatography, Dissolution, FTIR

• Analytical Chemist III

  • Jan 2019 - Jan 2021

• Analytical Chemist II

  • Jun 2016 - Jan 2019

• Analytical Chemist I

  • May 2012 - Jun 2016



Civitas Therapeutics

• Research Associate

  • Jan 2012 - Apr 2012

  Contract position.Summary: Worked as a member of the Analytical Development and Quality Control team at a small pharmaceutical/medical device company that specializes in pulmonary drug delivery on a proprietary low flow inhaler platform.- Performed analytical testing in a GMP environment.- Supported process development of inhalable spray-dried drug formulations.- Performed lot release and stability testing on inhalable spray-dried drug formulations.- Reviewed laboratory notebooks and data.- Tracked and maintained laboratory supplies.Skills: HPLC, KF Coulometry, Particle Size Determination by Cascade Impaction, Laser Diffraction, Tap Density



Wolfe Laboratories, Inc.

• Scientist I - Intern

  • Sep 2011 - Dec 2011

  Summary: Interned at a CRO that specializes in preclinical drug development. - Performed experiments to client specifications.- Performed media changes on Caco-2 cell line.- Assisted senior laboratory personnel with sample preparation, mobile phase preparation, etc.- Assisted QA with sorting, filing, data entry.- Reviewed laboratory notebooks and data.Skills: HPLC, LC/MS/MS, General wet chemistry techniques Summary: Interned at a CRO that specializes in preclinical drug development. - Performed experiments to client specifications.- Performed media changes on Caco-2 cell line.- Assisted senior laboratory personnel with sample preparation, mobile phase preparation, etc.- Assisted QA with sorting, filing, data entry.- Reviewed laboratory notebooks and data.Skills: HPLC, LC/MS/MS, General wet chemistry techniques