KIMBERLY VANWERT
South Amboy,NJ
Summary
Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.
Overview
10
10
years of professional experience
Work History
Manager, Manufacturing Shared Service, In-Process Materials Management
Bristol Myers Squibb
01.2021 - 07.2024
- Responsible for management of all Quality Control samples and materials in supporting analytical and microbiology laboratories at the CAR-T manufacturing facility
- Ensures the chain of custody and chain of identity of samples is maintained throughout the lifecyle of QCSM samples
- Promotes safe practices and behaviors
- Trains staff and holds them accountable for assignments
- Holds daily huddles with team and provides updates to the Managers
- Sets schedules for the shift and adjusts where necessary to meet timelines
- Ensures Deviations, CAPAs, and Change Controls are documented appropriately and closed in a timely manner
- Escalates issues
- Authors, reviews, and approves SOPs and other important documents
- Actively prepares for and participates in regulatory inspections
- Represents QCSM in various meetings and projects
- Performs other tasks as assigned
QC Scientist Shift Lead Sample Management
Bristol Myers Squibb
01.2020 - 01.2021
- Responsible for management of all Quality Control samples and materials in supporting analytical and microbiology laboratories at the CAR-T manufacturing facility
- Manages test samples throughout the sample lifecycle-receipt, storage, distribution, transfer, and disposal
- Maintains sample tracking and chain of custody records with GMP requirements and written procedures
- Working knowledge of lean laboratory principles
- Advanced ability to work in a collaborative team environment
- Advanced ability to understand, follow, interpret, and apply global regulatory and GMP requirements accurately and completely
- Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
- Sets priorities of the sample management group and manage timeliness
- Ensures expired or obsolete samples and materials are disposed of according to written procedures
- Assists management with investigations and deviations related to sample management
- Initiates deviations, change controls, and notice of events
Associate QC Scientist Sample Management
Celgene
10.2018 - 01.2020
- Responsible for the management of QC samples and materials in support of the analytical and microbiology CAR-T QC laboratories including materials inventory management, retains management and samples tracking and delivery
- Proficient in the use of LIMS, sample tracking software and CELabs
- Responsible for the management of test samples including receipt, storage, distribution and transfer and disposal
- Monitors the management of the long-term storage of retains and reference samples
- Ensure expired samples/materials are disposed of according to written procedures
- Assist management with investigations and deviations related to sample management
- Assist with cold chain sample storage and transfers
- Qualified trainer, trains laboratory and production personnel on the sample management process
- Responsible for inventory management of lab supplies including reagents, media, consumables and to ensure materials are appropriately labelled and traceable as per cGMP regulatory requirements
- Liaise with supply chain, warehouse, and lab services to ensure supply stocks
- Perform samples queries and periodic storage reports
Laboratory Scientist III
GENEWIZ, Inc.
10.2014 - 10.2018
- Independently carries out DNA sequencing services via CE: preparation, PCR amplification, gel electrophoresis and sequencing data analysis for customer submitted samples, as well as internal research and development projects
- Prepared buffers, dilutions, primers, and related solutions
- Performed Rolling Circle Amplification
- Train entry level employees on laboratory skills and company mindset during laboratory environment via SOP's and CAPA's
- Cell Culture of bacteria colonies, glycerol stock and phage supernatant
- Executes all tasks associated with training, sample handling, project processing, and documentation in compliance with Standard Operating Procedures ('SOPs')
- Implements backup team leader duties such as sequencer troubleshooting and handling of VIP customer samples
- Operates and maintains ABI 3730xl sequencers and other common sequencing equipment, processes GLP and CLIA samples, and prepares sequencing template, including preparation, amplification and PCR purification
- Preformed routine maintenance/troubleshooting on DNA sequencers with Capillary Electrophoresis
- Interprets sequencing data and to independently trouble-shoot problems with sequencing, reactions, samples, equipment
- CLIA, OSHA, GLP and HIPAA certified
Education
Master of Science - Drug Discovery And Development
Rutgers University
New Brunswick, NJ05-2024
Bachelor of Science - Biology
Fairleigh Dickinson University
Morristown, NJ05.2010
Skills
- CAR-T Leadership, Collaboration & Process Development
- Clinical to commerical experience
- Deviation expert
- Revised SOPs improving processes
- Certified qualified trainer
- Highly proficient in Veeva Vault
- Yellow Belt Certified
- Analysis/Calibrations with SOPs
- Cell Culture/Bacteria Cultivation
- Data Analysis/Preparation of Reagents
- GMP/GDP/GLP
- Implement 5S principles and FIFO
- Aseptic & Sterile Environment
- Pipetting
- ELISA
- Centrifugation
- LIMS
- Sample Management
- PowerPoint, Word, Excel, Outlook, Smartsheet, SharePoint
- Staff management and delegation
Experttechnicalskills
- Yellow Belt Process Improvement Training Certified
- Proficient in the use of LIMS and sample tracking software, enterprise application software.
- PC Platforms, PowerPoint, Excel, Word, Outlook, SharePoint and Smartsheet.
Award for Integrity
In 2018, I received an award from Celgene, Inc., for investigating a misprint with chain of identity mislabel.
Timeline
Manager, Manufacturing Shared Service, In-Process Materials Management
Bristol Myers Squibb
01.2021 - 07.2024
QC Scientist Shift Lead Sample Management
Bristol Myers Squibb
01.2020 - 01.2021
Associate QC Scientist Sample Management
Celgene
10.2018 - 01.2020
Laboratory Scientist III
GENEWIZ, Inc.
10.2014 - 10.2018
Master of Science - Drug Discovery And Development
Rutgers University
Bachelor of Science - Biology
Fairleigh Dickinson University
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