Nadim Mohamed
Woodbridge,NJ
Summary
Fresh biomedical engineering graduate of NJIT with a strong academic foundation in medical device design, biomaterials, and biomedical engineering. Currently thriving as a CAR-T Manufacturing Associate at Johnson and Johnson, where I apply my knowledge and skills to ensure the efficient production of pharmaceuticals while maintaining high levels of quality and safety standards. Skilled in operating and maintaining equipment, troubleshooting production issues, and collaborating with cross-functional teams to optimize manufacturing processes. Eager to leverage my technical expertise and contribute to the production of life-saving medications in a dynamic pharmaceutical industry setting. Skills: Strong background in technical writing & project documentation including the orchestration of ISO standardized project test plans, work breakdown structures, requirements documents, FDA regulations for medical devices, NIH research proposals, etc. Proficient expertise in MS project, Parametric Modeling, Assembly design & simulation, Design Drawings, Finite Element Analysis, CAD, 3D Printing etc. Experienced in simulation tools such as ANSYS, Simulink, and COMSOL as well as programming skills in MATLAB.
Overview
2
2
years of professional experience
Work History
CAR-T Manufacturing Operator
Johnson & Johnson
06.2024 - Current
- Support the development of manufacturing processes, and work with others to drive continuous improvements and efficiencies with cell therapy Technical Operations.
- Executed site qualification activities including Environmental Monitoring Performance Qualification (EMPQ) and Aseptic Process Simulation (APS).
- Familiarized with QC release testing and instrumentation including cell viability measurements, sterility testing, flow cytometry, centrifuging and microscopy.
- Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.
- Conduct process unit operations (i.e. cell culture, purification, and aseptic processing) according to standard operating procedures and batch records, record production data and information in a clear, concise format according to Good Document Practices (GDP).
- Collaborated with manufacturing excellence to improve personnel and material flow by relocating equipment based on process needs along with drafting/modifying relevant SOPs.
- Participating in designing new practice lab used to support Aseptic Process Qualification activities as well as general Operator Trainings.
- Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.
- Provide leadership to incoming operators and aid in their development.
- Trained new employees on company policies, equipment operation, and best practices, fostering a positive work environment and team cohesion.
- Provided timely feedback to management regarding potential bottlenecks within the production process, facilitating prompt resolution and minimizing disruptions.
Manufacturing Associate
Bristol Myers Squibb
08.2023 - 06.2024
- Adhered to GMP and GDP requirements utilizing aseptic techniques to produce ABECMA, a transformative CAR-T cell therapy for multiple myeloma patients.
- Responsible for aseptic sterile cleanroom operations and adherence to GMP and GLP guidelines enables execution of operations while maintaining the highest standards of product integrity.
- Collaborated effectively with cross-functional teams to meet production goals and contribute to improving patients' lives.
- Participated in regular team meetings to discuss progress, address challenges, and align on strategies for achieving production goals.
Lab Assistant
NJIT
01.2023 - 06.2023
- Performed cell and tissue culture.
- Worked with FT-IR spectroscopy and tensile testing of biomaterials using Instron testing machines.
- Assisted in performing protein synthesis using bioreactor flow device using solid-phase process.
- Performed Bradford protein Assay and Image analysis.
- Performed Bradford protein Assay and Image analysis.
Education
B.S. - Biomedical Engineering
New Jersey Institute of Technology
Newark, NJ05.2023
Skills
- Aseptic Techniques
- Good Manufacturing Practices
- Good Documentation Practices
- Good Laboratory Practices
- BSC skills
- Batch Records
- ENGINEERING ANALYSIS AND SIMULATION
- DESIGN DOCUMENTATION & TECHNICAL WRITING
- Risk Management
- Task Delegation/Team coordination
- Visual inspection
- Problem-solving
Timeline
CAR-T Manufacturing Operator
Johnson & Johnson
06.2024 - Current
Manufacturing Associate
Bristol Myers Squibb
08.2023 - 06.2024
Lab Assistant
NJIT
01.2023 - 06.2023
B.S. - Biomedical Engineering
New Jersey Institute of Technology
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