Timothy (T.J.) Blankenship Jr
Fuquay-Varina,North Carolina
Summary
Manufacturing associate with proven track record of high productivity and swift task completion. Specialized in quality control machinery operation and safety protocols, ensuring excellence in production environments. Strong team collaborator with problem-solving skills and adaptability, enhancing manufacturing processes. Extensive knowledge in clinical laboratory operations, punctual and professional, capable of working various shifts effectively.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Manufacturing Associate III / CQV
Fujifilm Diosynth Biotechnologies
Holly Springs, NC
01.2023 - Current
- Assisted in the development and execution of cGMP and cGDP protocols and documentation using Kneat, such as User Requirement Specifications (URS), Requirements Trace Matrix (RTM), Design Qualifications (DQ), and Factory Acceptance Test (FAT) Protocols.
- Assisted in the development of documents, including Job Hazard Analysis (JHA) and Risk Assessments (RA).
- Assisted in the development and execution of Site Acceptance Test (SAT) protocols and test cases.
- Assisted in the development and execution of Installation Verification (IV) Protocols, and Test Cases.
- Collaborated closely with cross-functional teams to ensure the proper qualification, testing, and documentation of equipment.
- Performed PQ Water (WFI and WPU) sampling of equipment utilizing LIMS software.
- Performed batch orders for water runs, technical runs, and engineering runs, utilizing Delta V and Syncade Engineering systems.
- Performed the preparation of media for cell growth and fermentation processes.
- Subject Matter Expert (SME) on-site parts washers, additionally provided training on equipment.
- Performed bagging and bottling in media prep, additionally utilizing the filter transfer station for the transfer of media into bioreactors.
- Performed operational, validation, and qualification testing, and water runs for upstream equipment.
- Assisted in the training of team members for multiple manufacturing areas and pieces of equipment.
- Assisted on Factory Acceptance Testing (FAT) of equipment and equipment skids for upstream systems, including bioreactors, nutrient/media tanks, filter transfer stations, centrifuges, downstream systems, including buffer/product hold, buffer prep, process support equipment (PSE), including parts washers, autoclaves, biosafety cabinets (BSC), laminar flow hoods/modules, and clean utility systems, including:
- General Arrangement (GA) Walkdowns.
- Piping and Instrument Drawing (P&ID) Walkdowns
- Component and Instrument Verification
- Agitator Testing.
- Riboflavin Spray Coverage Testing
- Drainability Testing
- Documentation review, including the verification of materials of construction, material test reports, and bill of materials.
- Operated manufacturing equipment to produce biopharmaceutical products.
- Followed safety protocols to maintain a safe working environment.
- Collaborated with team members to ensure efficient workflow and production schedules.
- Conducted routine inspections of machinery for maintenance and troubleshooting.
- Monitored inventory levels and reported discrepancies to ensure adequate supply availability.
- Donned safety glasses, gloves, and safety shoes to reduce injuries and accidents.
- Maintained production facilities at high standard of cleanliness and organization to improve quality of products.
Quality control and quality assurance Chemical lab intern
Huntington sanitary board
Huntington, WV
03.2022 - 07.2022
- Performed daily calibration and temperature checks on pH, dissolved oxygen, conductivity, and various machinery.
- Collected daily samples for comprehensive analysis.
- Ensured compliance with detection limit guidelines from West Virginia Department of Environmental Protection and Federal Environmental Protection Agency.
- Analyzed samples for total residual chlorine, pH, dissolved oxygen, and fecal coliform levels.
- Conducted UV-spectroscopy analysis on effluent water to verify proper disposal conditions for total residual chlorine.
- Utilized microscopy to quantify and qualify microorganisms, including rotifers and cilia.
- Executed settleability tests to evaluate settling and separation characteristics of activated sludge mixed liquor suspended solids.
- Maintained cleanliness and organization of the laboratory workspace and equipment.
- Conducted experiments according to established protocols under the supervision of a lab manager.
Undergraduate Research Lab
Marshall University
Huntington, WV
11.2018 - 05.2020
- Calibrated SPR instrumentation and analytical balance.
- Used desalting and diafiltration to remove salts and solvents from solutions containing biomolecules.
- Used a centrifugal process to achieve maximum polymerase chain reaction product recovery and primer removal.
- Synthesized monolayers and multiple generations of dendrimers.
- Applied external stimuli to monolayers, and calculated molecules in self-assembled monolayers.
- Used Microsoft Office to portray data gathered from experiments.
Education
Master of Business Administration (MBA) -
Stetson University
DeLand, Florida12.2028
Master of Science (M.S.) - Pharmaceutical Science with a Concentration in Pharmaceutical Chemistry
University of Florida
Gainesville, Florida12.2027
Bachelor of Science - Forensic Chemistry and Criminal Justice
Marshall University
Huntington, West Virginia12.2022
Skills
- Microsoft Office Suite
- Team leadership
- Polymer synthesis
- Laboratory management
- Report writing
- Grant writing
- Research proposals
- Titration techniques
- Nuclear magnetic resonance (NMR)
- Surface plasmon resonance (SPR)
- SDS-PAGE
- Gel electrophoresis
- Infrared spectroscopy
- Bomb calorimetry
- Spectrophotometry
- High performance liquid chromatography (HPLC)
- Gas chromatography-mass spectrometry (GC-MS)
- Liquid chromatography-mass spectrometry (LC-MS)
- UV-visible spectroscopy
- Quality assurance
- Regulatory compliance
- Data analysis
- Cross-functional collaboration
Certification
- CITI Program for Human Research – Chemistry Ethics
- Lean Six Sigma White Belt
- Manufacturing Bio Bootcamp for Fujifilm Diosynth Biotechnologies
- Includes training in Upstream/Downstream Processing, Aseptic Processing, cGMP, Root Cause Analysis, Micropipetting Techniques for Precision and Accuracy, and FDA Audits
- Crucial Conversations: Giving and Receiving Feedback
- Confined Space Entry Rescue
- Lock-Out Tag Out (LOTO) Authorized User
- Fall Protection Authorized User
Timeline
Manufacturing Associate III / CQV
Fujifilm Diosynth Biotechnologies
01.2023 - Current
Quality control and quality assurance Chemical lab intern
Huntington sanitary board
03.2022 - 07.2022
Undergraduate Research Lab
Marshall University
11.2018 - 05.2020
Master of Business Administration (MBA) -
Stetson University
Master of Science (M.S.) - Pharmaceutical Science with a Concentration in Pharmaceutical Chemistry
University of Florida
Bachelor of Science - Forensic Chemistry and Criminal Justice
Marshall University