Holly Zaradkiewicz Roosevelt,NJ ***** adxme3@r.postjobfree.com 1-732-***-****

I am an Upstream Manufacturing Tech 2/ Training Coordinator and Certified Surgical Technician with 15 years of experience within MTF Biologics, Thermo Fisher and Wuxi Biologics Pharmaceutical. I have a strong desire to learn new processes to better myself and to be an asset to the company. Experience working and teaching in multiple departments. As well as a proven knowledge of data collection, analysis, laboratory management, and clinical services. Aiming to learn, work hard also leverage my skills to successfully fill a role in which I can utilize my experiences and knowledge to help and teach others so we all can grow as a company.

Work Experience

Upstream Manufacturing Technician 2/ Training Coordinator

Wuxi Biologics-Cranbury, N.J.

September 2022 to Present

Working with mammalian cells for Cell Banking and Bioreactors.

Work closely with QC, QA, Downstream, F&E, Warehouse Associates as well as our Upstream team to maintain a smooth flow of communication for our processes.

Execute Batch records, SOP’s, Batch Reviews and Room releases

Stainless Steel Equipment’s: Bioreactors-200, 250, 500 and 2000. Rockers, BGA, Cedex, Vi-Cell, Osmo meter, Auto clave, Welder, Sealers, Pumps, Table top Centerfuges, Water baths, Incubators Pipettes, Micro-Pipettes, LN2 and CIP

Also informed with the Delta-V, FMS, MFCS, SAP systems

Ordering supplies for daily use as well as per process

Working with new hires and Training them as per SOP and Master Control

Training OJT for BSC, Media fill and Gowning in procedures

Daily Maintenance of machines, feeds and sampling.

Working closely with Managers, Supervisors and Team leads to set up Training Schedules.

Handling of Glucose, Media, Feeds, Sodium Hydrate, Antifoam, WIFI, and Buffer Dilutions

Scientist I Cell Processing Operations Thermo Fisher Scientific – Princeton, NJ January 2022 to June 16, 2022

Experience in the execution of T-Cell processing manufacturing activities in laboratory.

Conducting Laboratory processes while in full PPE with aseptic techniques.

Use aseptic techniques in a closed system within Biosafety Cabinet in ISO 5.

Directly involved in the process of harvesting terminally ill donor blood cells.

Learned to use the Elutra, Rotea, Bead bath, Cell Inlet Pump, Sysmex, Micro Pipettes, Sealers, Welders, Plasma Therm, Cellometer, Sepax, LN2 freezers, and etc.

Involved in the process of Isolation, activation and cryopreservation of T-Cells, Monocytes, RBCs, WBCs, and Media waste.

Generate multi-targeted T-Cells.

Formulate final product expressing specific tumor antigens.

Execution manufacturing batch record per work instruction in ISO 5.

cGMP, SOP compliant, fully trained to follow aseptic techniques and procedures in the Biosafety Cabinet, Clean rooms and ISO Class 7 rooms as well.

Requesting, preparing and editing log books, MBR’s and kits for all processes.

Use root cause analysis, review batch records for deviations, corrections, identify and aid in investigations.

Write and publish Non-conformance reports (NCR), deviations as well as CAPA’s .

Formulate and perform accurate calculations of cell Concentrations, Cryo and Cell Media dilutions

Perform pre-process activities, clean BSC, clean equipment, supplies and warm media

Perform Environmental Monitoring SAS/ Climet for and with QA.

Experience in cell therapy automation technologies using cell washers and Cell separation.

10+ years of GMP manufacturing experience.

Muscular Skeletal Transplant Foundation

M.T.F – Edison, NJ

July 2011 – January 2022

Dermis Master Processing Technician/Trainer, MTF

November 2018 – January 2022

Perform Aseptic process of Dermal layers, Placenta, Adipose and Subdermal layers within ISO Class 4&5 in the Laboratory and BSC.

Responsible for Aseptically measuring, chemical rinses, hair removal and putting into Disinfection solutions stations.

Setting up and using Grinding machine, Centerfuge, Shaker and scales for processing, separation, weighing and mixing Adipose and Chemical rinses for finished goods.

Following Good Documentations as per cGMP, SOP, GMP and FDA assigned processes. As well aseptically cleaning all class 4 & 5 BSC and rooms.

Mastering all processes as well as training all new hires as well as taking over for Team leaders/Supervisors when needed.

Becoming the official 2nd verifier for all processes to help with reducing Errors, Deviations and NCR’s. And being the only Technician to be certified in sink swab and water sampling for QA.

DBX Master Processing Technician/Trainer, MTF

April 2013 – October 2018

While using FM5 Milling Machines to grind down Cortical, Cancellous and Australian donors weighing them and separating as per SOP.

Using an ADS system or manually using Demineralizing mixing machine combining donor with chemicals to kill any living thing without damaging the bones.

Use putty/paste mixing with cortical to put into syringes labeling and sealing them for finish good process.

Using air suction machine to take Dental donor and put into air pressure machine and electrically zap for no static electricity within donor.

Using Sealing/ Capping machine for finished goods and using LYO machine for final seal of product before packaging and reconciliation.

Mastered all processes within the DBX department and responsible to train all new hires.

Gowned in Certified and working daily in ISO Class 4&5 while following all cGMP, SOP, FDA and OSHA regulations.

Sterilization Master Technician/ Trainer, MTF

July 2011 – May 2013

I have training and knowledge of Aseptic Techniques as well as working in ISO class 5,7 & 8.

Having to collect, weigh and check all Hazardous waste. Boxing and sealing them ready for removal. Also having to lift and move 50 lbs daily.

Experienced in loading, labeling, and checking all supplies and kits while using Good Documentation Practice to be ready to set up and run all Auto Claves.

Using Ultra Sonic System and Disinfection sinks to clean and put together all kits and supplies for all Aseptic processes.

Responsible for ordering and packaging all supplies and liquids for clean room processes. Passing in all sterile supplies and chemicals into clean room and into ISO class 5

Circulating inside clean rooms and responsible disinfecting locker rooms, filling scrub machine, cleaning shoe room and cleaning Laboratory rooms daily as well as training all new hires.

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