Project Manager

• Oct 2022 - Present

• Manage both commercial and early to late-stage API development projects simultaneously within a regulated environment• Provide a high level of service in order to maintain and improve customer relations by being a central point of contact for both internal and external customers.• Generate Gantt charts and timeline trackers used to direct internal operations to execute client projects within a defined scope of work• Provide financial project related forecasting to both internal and external clients• Review/author scope change orders, technical documents, supply agreements, and variouscustomer proposals• Produce technical presentations and facilitate weekly internal and external teleconferencecalls• Review, Manage and accept Purchase Orders within the internal enterprise system.• Work closely with Quality Assurance, Quality Control, Process Development, and AnalyticalDevelopment teams to ensure client deliverables are met in a timely fashion. Show less

Associate Project Manager

• Oct 2021 - Oct 2022

Research Scientist

• Jul 2019 - Oct 2021

• Author and Execute Method Validation Protocols for product-specific Raw Material, Intermediates, and APIs. • Develop and optimize cleaning assay methods for in-process and final API products.• Execute robustness studies on APIs and produce reports highlighting critical method parameters. • Peer review lab data, method development summary reports, and non-conformance reports.• Author Method Validation and Method Development Summary reports.• Generate/update/review Standard Test Methods to ensure proper tech-transfer to Quality Control Department for future routine analysis. • Actively participate in client conference calls to effectively communicate and remedy analytical challenges.◇ Perform Standard Test Method validations and write Method Validation Summary reports for analyzing future commercial drug product manufacturing.◇ Provide subject matter expertise regarding validated test methods.◇ Train incoming analysts on analytical equipment for method validation and method development.◇ Troubleshoot analytical methods/equipment when encountering problems.◇ Maintain all analytical equipment by performing routine PM/PVs. Show less

Chemist I

• Jun 2016 - Jul 2019

• Performed routine analytical tests in Non-GMP and GMP environments for product release, conducted tests such as High Performance Liquid Chromatographic Assay, Gas Chromatographic analysis for residual solvents, UV-Vis, sulfated ash, titration, heavy metals, IR, Karl Fischer, Fluorometer, Particle Size, and non-volatile residues on API products.• Peer Reviewed lab data for passing/failing results and ensured analysis was performed in accordance to Standard Test Methods and Regis Standard Operating Procedures.• Updated and revised quality documents to current company practices.• Opened lab investigations for Out of Specification results and entered tracking and trending data for all commercial production of APIs.• Performed Weekly/Quarterly/Monthly/Annual calibration of Analytical Instrumentation for GMP analysis e.g. HPLC, GC, and KF.◇ Resided on a validation core team to bring a single product to commercial production.◇ Provided subject matter expertise regarding all STMs for a single API.◇ Trained incoming analysts on GMP analysis of currently manufactured APIs. Show less

Pharmacy Technician

• Aug 2012 - Oct 2016

• Entered Prescription data with minimal error rate, resolving exceptions/issues in a timely manner to ensure prescriptions are properly dispensed.• Order and maintain pharmacy inventory to ensure company store funds are accounted for.• Communicate via telephone/email with patients, physicians, and insurance providers.• Refill/sell prescriptions to customers and guide them to over-the-counter products.• Process and troubleshoot insurance claims through proprietary software.• Follow state/federal regulations regarding controlled substances for filling and dispensing prescription medications. Show less

Photo Specialist

• Sep 2007 - Jul 2012

• Processed/developed customer film, passports, and photo calendars.• Maintained photo machines by changing processing chemicals and completing repairs as needed.• Placed current price prompts and sales ad-tags on display to support operations.

Chemist 1

• Jun 2015 - Oct 2015

• Performed routine analytical tests in GMP environment for product release, conducting tests such as UV-Vis, sulfated ash, titration, heavy metals, IR, Karl Fischer, and non-volatile residues on API products. • Entered product release results into SAP enterprise system to ensure timely production of pharmaceutical drugs. • Worked in analytical departments, inputting validation data for laboratory information management software (LIMS software). • Searched for references to support pharmaceutical development projects, allowing Abbvie to maintain compliance with Melamine guidelines set by the FDA. ◇ Developed/cataloged instrument database for launch of an Electronic Laboratory Notebook Software (ELN). ◇ Improved analyst efficiency and productivity, by formulating and creating spreadsheets to track incoming/outgoing GC and HPLC columns used for product testing. Show less

Summer Contractor

• May 2012 - Aug 2012

• Performed routine analytical tests in GMP environment for product release, conducting tests such as UV-Vis, sulfated ash, titration, heavy metals, IR, Karl Fischer, and non-volatile residues on API products. • Entered product release results into SAP enterprise system to ensure timely production of pharmaceutical drugs. • Worked in analytical departments, inputting validation data for laboratory information management software (LIMS software). • Searched for references to support pharmaceutical development projects, allowing Abbvie to maintain compliance with Melamine guidelines set by the FDA. ◇ Developed/cataloged instrument database for launch of an Electronic Laboratory Notebook Software (ELN). ◇ Improved analyst efficiency and productivity, by formulating and creating spreadsheets to track incoming/outgoing GC and HPLC columns used for product testing. Show less