Experience

Ocular Therapeutix, Inc.

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Product Development Manager

  • Jul 2023 - Present

  ● Design and perform process development activities for novel sustained release drug products. ● Analyze and evaluate the impact of formulation and process variables on drug product characteristics. ● Manufacture drug product batches to support preclinical to Phase III clinical studies ● Develop scalable and validatable manufacturing processes by conducting appropriate risk assessments. ● Communicate study design, data analysis and results to technical team members. ●… Show more ● Design and perform process development activities for novel sustained release drug products. ● Analyze and evaluate the impact of formulation and process variables on drug product characteristics. ● Manufacture drug product batches to support preclinical to Phase III clinical studies ● Develop scalable and validatable manufacturing processes by conducting appropriate risk assessments. ● Communicate study design, data analysis and results to technical team members. ● Communicate project plans, status updates and progress against milestones to project team members. ● Generation of technical documents and reports. ● Complete early and mid-stage drug product development for transfer to commercial production.

• Senior Engineer

  • Aug 2021 - Jun 2023

  ● Design and perform process development activities for novel sustained release drug products. ● Analyze and evaluate the impact of formulation and process variables on drug product characteristics. ● Manufacture drug product batches to support preclinical to Phase III clinical studies ● Develop scalable and validatable manufacturing processes by conducting appropriate risk assessments. ● Communicate study design, data analysis and results to technical team members. ●… Show more ● Design and perform process development activities for novel sustained release drug products. ● Analyze and evaluate the impact of formulation and process variables on drug product characteristics. ● Manufacture drug product batches to support preclinical to Phase III clinical studies ● Develop scalable and validatable manufacturing processes by conducting appropriate risk assessments. ● Communicate study design, data analysis and results to technical team members. ● Communicate project plans, status updates and progress against milestones to project team members. ● Generation of technical documents and reports. ● Complete early and mid-stage drug product development for transfer to commercial production.



Berkshire Sterile Manufacturing

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Equipment Manager

  • Dec 2019 - Jul 2021

  ● Manages all cGMP equipment used in the facility, including equipment selection, equipment upgrades, equipment troubleshooting and repairs. ● Supervises and leads facility engineers and associates. Assigns projects and monitors results. ● Manages equipment issues through support ticket generation, tracking and resolution. ● Responsible for preventive maintenance and calibration programs. ● Coordinates activities with vendors, internal resources and supporting contractors to… Show more ● Manages all cGMP equipment used in the facility, including equipment selection, equipment upgrades, equipment troubleshooting and repairs. ● Supervises and leads facility engineers and associates. Assigns projects and monitors results. ● Manages equipment issues through support ticket generation, tracking and resolution. ● Responsible for preventive maintenance and calibration programs. ● Coordinates activities with vendors, internal resources and supporting contractors to calibrate, maintain, or troubleshoot systems. ● Provides expertise for audit inquires, deviations, corrective actions and method of change quality events. Show less ● Manages all cGMP equipment used in the facility, including equipment selection, equipment upgrades, equipment troubleshooting and repairs. ● Supervises and leads facility engineers and associates. Assigns projects and monitors results. ● Manages equipment issues through support ticket generation, tracking and resolution. ● Responsible for preventive maintenance and calibration programs. ● Coordinates activities with vendors, internal resources and supporting contractors to… Show more ● Manages all cGMP equipment used in the facility, including equipment selection, equipment upgrades, equipment troubleshooting and repairs. ● Supervises and leads facility engineers and associates. Assigns projects and monitors results. ● Manages equipment issues through support ticket generation, tracking and resolution. ● Responsible for preventive maintenance and calibration programs. ● Coordinates activities with vendors, internal resources and supporting contractors to calibrate, maintain, or troubleshoot systems. ● Provides expertise for audit inquires, deviations, corrective actions and method of change quality events. Show less



Compass Biomedical

• United States
• Biotechnology
• 1 - 100 Employee

• Engineer

  • Nov 2012 - Dec 2019

  ● Established design project plans, scope, schedules, budgets, and deliverables ● Responsible for authoring, executing and review/approval of design documentation, validation protocols (IQ/OQ/PQ), and process validation. ● Developed and performed small scale proof of concept testing for new product development. ● Developed product requirements/specifications, and performed risk analysis for new design projects. ● Coordinated the purchase/installation of equipment, disposables and… Show more ● Established design project plans, scope, schedules, budgets, and deliverables ● Responsible for authoring, executing and review/approval of design documentation, validation protocols (IQ/OQ/PQ), and process validation. ● Developed and performed small scale proof of concept testing for new product development. ● Developed product requirements/specifications, and performed risk analysis for new design projects. ● Coordinated the purchase/installation of equipment, disposables and utilities with outside vendors based on project requirements/specifications. ● Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, methods and laboratory instruments. ● Reviews and authors work instructions, SOPs, batch records in cGMP facility. ● Responsible for supporting the qualification, calibration and maintenance of cGMP utilities, manufacturing process equipment and laboratory equipment ● Implemented and Enforce Safety Plans based on OSHA Standards ● Written Safety proposals, developed training, interrupted regulations and conducted safety training. Show less ● Established design project plans, scope, schedules, budgets, and deliverables ● Responsible for authoring, executing and review/approval of design documentation, validation protocols (IQ/OQ/PQ), and process validation. ● Developed and performed small scale proof of concept testing for new product development. ● Developed product requirements/specifications, and performed risk analysis for new design projects. ● Coordinated the purchase/installation of equipment, disposables and… Show more ● Established design project plans, scope, schedules, budgets, and deliverables ● Responsible for authoring, executing and review/approval of design documentation, validation protocols (IQ/OQ/PQ), and process validation. ● Developed and performed small scale proof of concept testing for new product development. ● Developed product requirements/specifications, and performed risk analysis for new design projects. ● Coordinated the purchase/installation of equipment, disposables and utilities with outside vendors based on project requirements/specifications. ● Reviews and assists in investigating deviations related to manufacturing process equipment, utilities, methods and laboratory instruments. ● Reviews and authors work instructions, SOPs, batch records in cGMP facility. ● Responsible for supporting the qualification, calibration and maintenance of cGMP utilities, manufacturing process equipment and laboratory equipment ● Implemented and Enforce Safety Plans based on OSHA Standards ● Written Safety proposals, developed training, interrupted regulations and conducted safety training. Show less



Arteriocyte (Now Isto Biologics)

• Medical Device
• 1 - 100 Employee

• Associate Scientist

  • Nov 2012 - Aug 2016

  ● Technical writing including: grants, conferences, protocols and reports ● Design and development a bioactive collagen foam bandage for wound healing applications. ● Developed product formulation, freeze dry cycle and manufacturing process. ● Design and development of an oxygen sensing bandage for wound diagnostics. ● Development included custom imaging/optical systems. ● Developed custom oxygen and temperature calibration chamber to test the product. ● Developed multiple… Show more ● Technical writing including: grants, conferences, protocols and reports ● Design and development a bioactive collagen foam bandage for wound healing applications. ● Developed product formulation, freeze dry cycle and manufacturing process. ● Design and development of an oxygen sensing bandage for wound diagnostics. ● Development included custom imaging/optical systems. ● Developed custom oxygen and temperature calibration chamber to test the product. ● Developed multiple iterations of the oxygen sensing bandages/films including polymer casting, extrusion, microparticle and hydrogel formulations. ● Developed an antibiotic loaded bone graft product for infection prevention in spinal fusion. ● Analyzed and tailored release kinetics of the antibiotic loaded osteogenic scaffold. ● Successfully developed custom fixtures and equipment for the scale-up of an electrospun cell culture scaffold product. ● Performed or contracted all equipment maintenance and calibration of equipment. ● Performed cell culture experiments for product testing and marketing data. ● Trained interns and new employees on laboratory skills. ● Trained Phlebotomist - Performed blood draws for in house product testing. ● Safety Officer Show less ● Technical writing including: grants, conferences, protocols and reports ● Design and development a bioactive collagen foam bandage for wound healing applications. ● Developed product formulation, freeze dry cycle and manufacturing process. ● Design and development of an oxygen sensing bandage for wound diagnostics. ● Development included custom imaging/optical systems. ● Developed custom oxygen and temperature calibration chamber to test the product. ● Developed multiple… Show more ● Technical writing including: grants, conferences, protocols and reports ● Design and development a bioactive collagen foam bandage for wound healing applications. ● Developed product formulation, freeze dry cycle and manufacturing process. ● Design and development of an oxygen sensing bandage for wound diagnostics. ● Development included custom imaging/optical systems. ● Developed custom oxygen and temperature calibration chamber to test the product. ● Developed multiple iterations of the oxygen sensing bandages/films including polymer casting, extrusion, microparticle and hydrogel formulations. ● Developed an antibiotic loaded bone graft product for infection prevention in spinal fusion. ● Analyzed and tailored release kinetics of the antibiotic loaded osteogenic scaffold. ● Successfully developed custom fixtures and equipment for the scale-up of an electrospun cell culture scaffold product. ● Performed or contracted all equipment maintenance and calibration of equipment. ● Performed cell culture experiments for product testing and marketing data. ● Trained interns and new employees on laboratory skills. ● Trained Phlebotomist - Performed blood draws for in house product testing. ● Safety Officer Show less



The University of Akron

• United States
• Higher Education
• 700 & Above Employee

• Research Assistant

  • May 2010 - May 2012

  ● Generate reports for technical conferences and presentations in accordance with their prescribed guidelines. ● Set-up and maintained cell culture laboratory including equipment upkeep, ordering supplies and cleanup. ● Primary stem cells culture of rMSC, rNSC and hMSC’s. ● Trained graduate and undergraduate assistants in laboratory work and delegated tasks. ● Testing of hydrogels with rheology and hydrogel sythesis ● Fluorescence microscopy, immunofluorescence assays, and… Show more ● Generate reports for technical conferences and presentations in accordance with their prescribed guidelines. ● Set-up and maintained cell culture laboratory including equipment upkeep, ordering supplies and cleanup. ● Primary stem cells culture of rMSC, rNSC and hMSC’s. ● Trained graduate and undergraduate assistants in laboratory work and delegated tasks. ● Testing of hydrogels with rheology and hydrogel sythesis ● Fluorescence microscopy, immunofluorescence assays, and image processing.

• Chemistry & Physics Lab Instructor

  • Aug 2009 - May 2010

  ● Assist students with laboratory assignments by helping them learn the basic goals of each lab. ● Prepare chemistry solutions for each lab section. ● Enforced The University of Akron’s lab policies and safety procedures.