Brenda Martell
Flemington,NJ
Summary
Demonstrated leadership ability by taking initiative in process improvement and cost reduction projects, completing additional tasks to meet scheduling demands, and fostering trust among team members and supervisors. Eager to assume a leadership position as a Manufacturing Lead Operator, utilizing my skills and expertise to contribute towards the company's growth in patient outreach.
Overview
3
3
years of professional experience
Work History
CAR-T Senior Operation Associate
Legend Biotech
05.2022 - Current
- Demonstrated leadership by resolving planning issues and troubleshooting MES problems, successfully overseeing daily tasks and recommending improvements to enhance team collaboration.
- Adaptable in handling stressful situations and identifying points of contact for issues beyond my expertise.
- Demonstrated adaptability within diverse team dynamics, fostering a cohesive working environment.
- Contributed to initiatives focused on minimizing material expenses, with a specific focus on kiting materials and Transact vials.
- Participated in process flow improvements and data risk assessments, utilizing my expertise.
- Participated in airflow visualization tests for the Laminar Flow Glovebox Isolator (LFG).
- Provided comprehensive training to newly hired employees regarding aseptic hand manipulation in the LFG. Training covered tasks such as cleaning the LFG, organizing materials, and gaining proficiency in implementing SOPs.
- Perform and verified aseptic manipulation in Laminar Flow Glovebox Isolator (LFG) manufacturing the component preparation of (Buffer, IL-2, G-Rex, TransAct, Complete Culture Media (CCM), Lenti Virus, CCHMC, and Aph Spike) for autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment.
- Contributed to operational expansion by aiding in the successful launch of twelve starts.
- Ensured accuracy of batch records through thorough peer reviews performed on paper and electronic (MES) records.
- Contributed to site qualification activities by assisting with Environmental Monitoring, Performance Qualification (EMPQ), and Aseptic Process Simulation (APS).
- Utilized SAP software to effectively monitor and manage batch deliveries, ensuring precise data collection for supply chain operations.
Tissue Manufacturing Operator
Celularity
11.2021 - 05.2022
- Assisted in the manufacturing of placenta-derived off-the-shelf allogenneic cell therapy products for clinical trials and commercial supply within a quality control environment.
- Trained new hires in placenta harvesting, final product packaging, cryomill operation, and aseptic manipulation using Biosafety Cabinet (BSC) and Control Horizontal Laminar Airflow Hood (LCD).
Education
Biomedical engineering -
New Jersey Institute of technology
01.2021
Skills
- Problem-solving
- Self-discipline
- Adaptability
- Prioritization
- Collaborative
- Initiative
Timeline
CAR-T Senior Operation Associate
Legend Biotech
05.2022 - Current
Tissue Manufacturing Operator
Celularity
11.2021 - 05.2022
Biomedical engineering -
New Jersey Institute of technology
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