Experience

BioAgilytix

• United States
• Biotechnology Research
• 700 & Above Employee

• Manager II

  • Apr 2023 - Present

  Raleigh-Durham-Chapel Hill Area •Lead scientific teams to develop and validate biomarker, immunogenicity, and pharmacokinetic assays in support of preclinical and clinical studies under GxP regulations. •Maintain client relations and work closely with clients to ensure successful on-time completion of projects and customer satisfaction •Manage project timelines and resources, forecast accurately to achieve corporate revenue targets

• Manager I

  • Jan 2020 - Apr 2023

  Raleigh-Durham-Chapel Hill Area

• Scientist III / Bioanalytical Project Manager

  • Jul 2018 - Jan 2020

  Raleigh-Durham, North Carolina Area • Manage assay validation and sample analysis project timelines, scheduling, budget and revenue. • Serves as lead scientist, working closely with team members to ensure successful on time execution of assays under GxP guidelines. • Perform statistical analysis, present data tables and posters, author reports and prepare SOPs. • Independently author plans and reports, prepare summary tables for validation and sample analysis • Communicate and present data to clients. • Conduct… Show more • Manage assay validation and sample analysis project timelines, scheduling, budget and revenue. • Serves as lead scientist, working closely with team members to ensure successful on time execution of assays under GxP guidelines. • Perform statistical analysis, present data tables and posters, author reports and prepare SOPs. • Independently author plans and reports, prepare summary tables for validation and sample analysis • Communicate and present data to clients. • Conduct Quality Control (QC) technical, scientific, and compliance review of data generated in support of regulated studies.

• Scientist II

  • Apr 2017 - Jan 2020

  Raleigh-Durham, North Carolina Area



Beacon Analytical Systems Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manufacturing Manager

  • Mar 2011 - Mar 2017

  Saco, ME •Managed daily operations of microtiter plate and tube ELISA test kit manufacturing including: production scheduling, inventory control, forecasting production requirements, raw material procurement, shipping and receiving. •Optimized manufacturing processes for cost reduction, lead time reduction, and quality improvement. •Successfully developed and implemented quality management system processes for ISO 9001:2015 certification. Completed stage 2 audit in November 2016. •Authored and… Show more •Managed daily operations of microtiter plate and tube ELISA test kit manufacturing including: production scheduling, inventory control, forecasting production requirements, raw material procurement, shipping and receiving. •Optimized manufacturing processes for cost reduction, lead time reduction, and quality improvement. •Successfully developed and implemented quality management system processes for ISO 9001:2015 certification. Completed stage 2 audit in November 2016. •Authored and reviewed standard operating procedures and work instructions for reagent preparation and product quality control. •Coordinated updating product labeling and safety data sheets for GHS compliance. •Interfaced with R&D staff regularly to prepare new products for launch and to modify existing product designs to meet customer needs. •Prepared and negotiated supply agreements with product distributors and raw material vendors. •Developed training programs for new and existing employees. •Coordinated with external IT company to plan and launch new company website.

• Manufacturing Lead - Production & Quality Control

  • Mar 2010 - Mar 2011

  Saco, ME •Led product reagent preparations involving wet chemistry techniques. Tasks included HRP conjugation, coating solution, buffer and standard solution preparations. •Planned and delivered highly customized build-to-order test kits to customers. •Trained and educated technical staff in all aspects of production, quality control, and product assembly/packaging under Good Manufacturing Practice (GMP).

• Manufacturing Specialist

  • Mar 2008 - Mar 2010

  Saco, ME •Prepared and qualified reagents for immunoassay test kits used in the detection of mycotoxins, algal toxins, antibiotic residues, and environmental contaminants. •Oversaw and maintained microtiter plate and test tube coating operations for immobilization of antibodies and antigens. •Provided customer technical support including running assays and results interpretation using Softmax Pro. •Conducted affinity purification and characterization of IgG and IgY polyclonal antibodies for… Show more •Prepared and qualified reagents for immunoassay test kits used in the detection of mycotoxins, algal toxins, antibiotic residues, and environmental contaminants. •Oversaw and maintained microtiter plate and test tube coating operations for immobilization of antibodies and antigens. •Provided customer technical support including running assays and results interpretation using Softmax Pro. •Conducted affinity purification and characterization of IgG and IgY polyclonal antibodies for large scale production use.