Anton Stetsenko Email & Phone Number

Millville, New Jersey, Us

Primary Responsibilities: Managing the quality department and responsible for quality assurance for three site locations with twelve direct reports.• Managed EHS for all North American sites.• Responsible for ISO conformity for the site• Monitored KPI’s and reported on Findings/Deviations• Managed and supported internal, supplier, and customer audits• Managed calibration and maintenance activities including coordination of activities and inventory control of a multitude of manufacturing assets. • Responsible for Document control for North America and completed the integration and setup of the document management system (SharePoint).• Managed the complaint handling and regulatory compliance team.• Drafted, reviewed, and routed NDA, quality agreement, and change notifications for North America.

Millville, New Jersey, Us

Primary Responsibilities: Managing the quality department and responsible for quality assurance for three site locations with nine direct reports. Managed calibration and maintenance activities including coordination of activities and inventory control of a multitude of manufacturing assets.  Responsible for Document control for North America and completed the integration and setup of the document management system (SharePoint). Managed the complaint handling and regulatory compliance team. Drafted, reviewed, and routed NDA, quality agreement, and change notifications for North America. Conducted and lead site audits, customer audits, and supplier audits.

• Drafted, executed and reviewed Commissioning and Installation/Operation Qualification (IOQ) protocols for Biopharmaceutical assets and utilities used in a high paced contract manufacturing facility. Some examples include the gas storage and distribution systems for Carbon dioxide, oxygen and clean compressed air, incubators humidity control, -20 and -80℃ freezers, cryogenic freezers, clean rooms architectural validation, and building automation system (BAS) validation. • Drafted and executed Component Level Risk Assessments (CLRA) for direct impact Biopharmaceutical assets and systems.• Conducted Computerized System Validation (CSV) assessment and field execution of test scripts on Biopharmaceutical assets such as Nova Flex Gas Testers, Repligen Tangential Flow Filtration System (TFF).• Preformed pre and post-calibration on kaye validators, in addition to temperature mapping of freezers, incubators, and cold rooms. • Completed pressure differential verification and smoke studies for biopharmaceutical suites.

• Used Blue Mountain Regulatory Asset Manager Software lead the effort for the entire greenfield manufacturing site to input major capital assets. Managed calibration and maintenance activities including coordination of activities and inventory control of a multitude of Biopharmaceutical assets. • Supervised and transferred methods and procedure over to client’s calibration contractors’ staff and ensured all work and the accompanying proper documentation was performed in accordance with state/local and Pharmaceutical cGMP requirements.• Ensured all calibration, Preventive Maintenance, and qualification activities and the corresponding records were filed appropriately after approval.• Physically installed assets such as probes, chart records, incubators in the field and tagged them with the proper client equipment numbers.

• Operated several types of pharmaceutical process equipment such as a vial & ampule filler, autoclave, parts washer, formulation bioreactor.• Weighed and formulated various injectable drug compounds.• Repaired and replaced parts of pharmaceutical machinery under the guidance of a mechanic (e.g. replacing the parts of the vial and ampule filler).• Managed inventory of sterile equipment and products.

• Scheduled and manage timelines using Microsoft Project for critical company expansion activities.• Work closely with the Topical, Injectable/Liquid in a Vial (LIV) and Lab divisions to ensure close alignment with greenfield construction and company’s transition from manufacturing topical to injectable products.• Purchased and tracked equipment and expenses using Systems Applications and Products in Data Processing software (SAP).• Drafted, finalized and reviewed SOPs (Standard Operating Procedures) and job aids for process equipment and common utility systems that are used in manufacturing plants. Some examples include bioreactors, vial/ampoule fillers, autoclaves and parts washers, clean compressed air system, Water for Injection MES stills, and point of use heat exchangers.

• Work in finish lab that I cut and edge lenses to be put into frames• Operate prescreening equipment, such as autorefractor/Keratometer, FDT (frequency doubling technology) and the NCT (non-contact tonometry)

Glassboro, Nj, Us

• Utilizing macromolecular memory and an advanced form of polymer engineering to create silicone hydrogel contact lenses capable of controlled drug release• Engineered contact lenses that are capable of releasing anti-inflammatory and antibiotic to treat post-cataract patients

Stratford, New Jersey, Us

• Researched ways to improve on cancer drug efficacy by focusing on the toxicology of the drug and inhibit the negative effects.• Analyzed cells using FACS (fluorescence activated cell sorting) to determine drug efficacy, RNA isolation, and cell culturing

Deerfield, Il, Us

• Sales- daily customer interaction, selling products and training new team members.

Maintained an efficient work pace. Primarily participated Mow, edge, lay, mulch down, trim small trees, and shrubs. Ensured friendly environment customer service for residents.Load and unload truck and picked and packed products.

Bachelor Of Science (B.S.), Biomedical/Medical Engineering

Associate Of Science (As), Engineering

High School Diploma, Engineering