manufacturing associate project lead and trainer resume example with 11+ years of experience

Jessica Claire
  • , San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Summary
Lead Cellular Therapy Specialist Enthusiastic and results-oriented professional, offering diverse expertise in cellular therapy manufacturing.
  • Academic
  • C
  • CLS
  • Concise
  • Contracts
  • Client
  • Delivery
  • Documentation
  • Essays
  • Forms
  • Good Laboratory Practice
  • GLP
  • Good Manufacturing Practice
  • GMP
  • Instruction
  • Inventory
  • Works
  • Monitors
  • Personnel
  • Progress
  • Project Management
  • Quality
  • Quality Assurance
  • Quality Control
  • Scheduling
  • SOP
  • Supply Chain Management
  • Technical training
  • Trainer
  • Written
  • Author
Work History
Manufacturing Associate – Project Lead and Trainer, 02/2019 - Current
Northwell Health Saint James, NY,
  • As the Operations lead and trainer of a complex, multi-day CAR T cellular therapy project, I serve as primary associate for that facilitates the planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts.
  • In this role, I lead the Manufacturing Operations activities for a group of associates; personnel within the department, delivering on-the-job technical training on a timely basis, including new hire training, aseptic technique and processing, cell culture basics, cell therapy specific equipment training, cGMP documentation and regulatory basics, as well as GLP/GDP general lab skills training.
  • Trains and onboards new manufacturing associates on general aseptic technique, and on process-specific manipulations and instrumentation.
  • Manages, schedules and a team of 5 manufacturing associates to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for a client project.
  • Manages the operation and readiness of a cleanroom (CER), including but not limited to:.
  • Maintaining appropriate levels of consumables in the CER,.
  • Performs and monitors environmental controls (Temp, Humidity, pressure differential, particle counter, microbial controls),.
  • Updating and requesting cleaning schedules as needed,.
  • Assess cleanrom capabilities and appropriate usage/scheduling.
  • Demonstrated proficiency operating Cells processing Systems:.
  • Sepax C-Pro, Xuri Cell Expansion System W25 Bioreactor,.
  • Clinimacs, CliniMACS Prodigy, Lovo Cell Processing System, G-Rex, and NucleoCounter NC-200.
  • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract.
  • Well versed in cGMP documentation and regulatory basics, as well as GLP/GDP general lab.
  • On hand experience with Technology transfers, leading manufacturing TT derivables for 2 highly complicated international projects.
  • Demonstrates mastery knowledge of Aseptic Cell Therapy Manufacturing and production.
  • Interacts with Client daily regarding project updates and improvements.
  • Experienced document author of general SOPs as well as process specific WIs and associated forms.
  • Utilizes 5S and Kanban techniques to maintain proper inventory and for general lab upkeep.
  • Works closely with Quality Assurance, Quality Control, Supply Chain Management, and Project Management to ensure successful manufacturing of the product for the Client.
  • Follows written Standard Operating Procedures (SOPs) and Work Instructions (WIs) in accordance to Good Laboratory Practice (GLP), Good Tissue Practice (GTP), and Good Manufacturing Practice (GMP).
  • Adheres to proper Good Documentation Practice (GDP) in and out of the cleanroom.
  • Expert in both bag and flask cellular culture manipulations.
Clinical Laboratory Technician, 06/2018 - 01/2019
  • Operates laboratory instruments and equipment for the processing of biological samples through the use of various assays.
  • Works directly with Clinical Laboratory Scientists to ensure safe specimen handling and high-quality patient results.
  • Troubleshoots both lab instrumentation and assay systems as needed.
  • Performs daily maintenance on all machines and keeps meticulous records of assays performed, specimens processed, and technical analyses of patient results and instrumentation function.
  • Performs daily QC and calibrations for lab instruments and assay systems.
  • Follows SOP guidelines, OSHA and HIPAA regulations.
  • Labels and appropriately archives specimen tubes into sample racks as well as in the online Laboratory Information System.
  • Identifies sub-optimal specimens that require the inspection of a CLS and communicates with CLS on tests that need to be run again or canceled.
  • Re-fills and re-stocks both reagents and consumables for all machines.
  • Keeps record of reagents and consumables used, stability date, and inputs information into online inventory system.
Private Academic Tutor, 09/2009 - 06/2018
  • Identified children's individual and collective learning needs, as well as prepared instruction to capture students' interest and maximize individual learning.
  • Effectively tutored a variety of elementary school to college-level students in all academic subjects.
  • Mentored students in writing concise lab reports and essays to progress by full letter grades by the end of the semester.
  • Delivered multiple study plans to facilitate the students and provided feedback to the students for improvement.
Developmental Biology, Oncology, Histology, Immunology, and Microbiology: Biological, Expected in 2021
UCLA - Extension,
Status -
Bachelor of Science: Biological Sciences, Expected in 2013
University of California - Santa Cruz, CA
Status -

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Resume Overview

School Attended

  • UCLA
  • University of California

Job Titles Held:

  • Manufacturing Associate – Project Lead and Trainer
  • Clinical Laboratory Technician
  • Private Academic Tutor


  • Developmental Biology, Oncology, Histology, Immunology, and Microbiology
  • Bachelor of Science

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