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Click here or scroll down to respond to this candidateCandidate's Name
Hillsborough, New JerseyPHONE NUMBER AVAILABLE EMAIL AVAILABLESKILLS:cGMP, CAD (SolidWorks), SAP/LIMS, LabView, Adobe Illustrator, MATLAB, MS Office (Word, Excel, PowerPoint), Introductory knowledge of Python and Java, SQL, Gas Chromatography, ELISA, SDS-PAGE, electrophoresis, flow cytometry, PCR, Gas Chromatography Projects, Six Sigma Methodologies Certificate, Packaging (Qualification, Testing,and Design), Graphic Design EDUCATION:Rutgers University, New Brunswick NJ Aug 2017-May 2021 Bachelor of Science Biomedical Engineering+ Packaging Engineering CertificateRelevant ClassworkBiomedical Transport Phenomena, Kinetics and Thermodynamics, Biomechanics, Biomaterials, BME Measurements and Analysis, Organic Chemistry 1&2, Numerical Modeling, BME Devices and Systems, Genetics, Systems Physiology, Tissue Engineering 1&2, Principles of Drug Delivery, BME Global Health SUMMARY:Performed thorough strict adherence to SOPs, documentation, manufacturing, and packaging, ensuring the integrity and compliance of each step in the pharmaceutical manufacturing process.Proficient in the execution of duties necessary to operate in a laboratory pharmaceutical environment from, aseptic technique, inventory management and control within a laboratory, as well as a strong background in maintaining detailed documentation and the analytical procedures of many different pieces of equipment to keep track of chemical inventory and perform analytical chemistry testing accurately and consistently.A result-oriented professional demonstrating a strong ability to create packaging components and control through meticulous management of quality records and implementation of robust quality control processes.Worked on process labeling and quality records according to SOPs and cGMP guidelines, ensuring accurate and standardized documentation and overseeing and conducting deviation investigations, employing root cause analysis tools, and actively participating in on-the-job training for Corrective and Preventive Action (CAPA) processes.RELEVANT EXPERIENCE:Merck, Rahway NJFeb 2023-May 2024Clinical Packaging Technician Performed Quality Assurance and Quality control responsibilities, to verify the quality of the material pre and post processing, and a yellow belt in Six Sigma. Using SAP software, processed labeling, and packaging batch record according to SOPs/cGMP. Performed preventative maintenance of laboratory equipment and instruments. Verified before use that equipment and room clean expiration date has not been exceeded. Performed all tasks related to clinical quality control and packaging. Performed and documented de-packaging, packaging, and labeling activities. Printed, inspected, and performed packaging trials. Maintained cGMP and safety training to site requirements; followed cGMP and safety requirements in all activities. Set-up, operated, and dis/assembled packaging equipment and room. Experienced in deviation investigations utilizing root cause analysis tools and CAPA processes; skilled in identifying and verifying effectiveness of updated procedures, writing investigations reports for atypical events in a manufacturing environment. Experienced in calibrating and qualifying packaging equipment. Performed quantitative analysis for pharmaceutical drug-substances, excipients and drug products using USP/NF, EP, in-house test methods and standard protocols, maintaining full compliance with all applicable US FDA - cGMP regulations and internal SOPs. AbbVie, Branchburg NJJan 2022-Dec 2022R&D/Calibration Technician IIWorked with blood samples to perform immunological assays. Used flow cytometry machine to test for the size of particulates and ELISA testing for the presence of antigens, also performed other types of testing.Used Polymerase Chain Reaction (PCR) machines to generate strains of genetic sequences. Worked with scientist to purify and extract those sequences.Responsible for the operation, maintenance and repair of grinding, purification, centrifugation and cryopreservation equipment.Performed benchtop polymer synthesis and scale-up using standard organic and polymer chemistry techniques.Performed chemical, physical, and instrumental analysis of ingredients and finished products.Performed HPLC, GC, TLC, UV testing and helped to calibrate their appropriate machines.Duties included handling of hazardous materials, maintaining inventory and ordering supplies through SAP, preparing buffers bulk formulation, filling, sub-assembly, and sample testing.Prepared and generated cell cultures to test for biological response when exposed to transplanted material.Used a bioreactor to increase the size of mammalian cell cultures to test project lines.Generated documentation for the calibration and validation of analytical lab equipment when R&D projects became elevated.Worked with a team of engineers and scientists in a clean room environment to manufacture and package medical devices.SGS Consumer Testing ServicesOct 2021-Jan 2022Technician, Materials & Packaging LabPerformed physical testing on products including plastic films, paper, rubber products and shipping containers as well as labeling the products appropriately for future processing.Routine operation, maintenance, and validation of laboratory equipment and instruments.Coordinated with others on sample receiving, logging, pretreatment, preparation, testing. Rutgers University,New Brunswick NJAug 2017-May 2021Undergraduate Research and ProjectsDeveloped nanoparticles less than 200nm to contract torn tissue to its original length, as well as to release molecules for tissue repair.Performed FMEA analysis on a biological model.Studied the effectiveness of Convalescent plasma therapy as a cure to COVID-19.Researchedon and presented 3D tissue implants that use plastics to increase striation and performance of muscle tissue in the respiratory track while leading a team of three other colleagues.Developed knowledge of CAR-T technologies and procedures such as harvest and media transfer through a research project |
