Michelle Kaspszak
Champlin,MN
Summary
Dedicated and detail-oriented professional with a decade of comprehensive experience in research and laboratory management. Known for driving laboratory operations, ensuring quality control, and fostering a culture of innovation. Adept at conducting experiments, developing laboratory procedures, and managing production, resulting in significant contributions to the organizations. Skilled in ISO 9001 standards, laboratory infrastructure maintenance, and quality assurance.
Overview
10
10
years of professional experience
Work History
Senior Research Associate / Scientist
Mindray
03.2022 - 11.2023
- Lead design and execution of experiments for development of chemiluminescence immunoassays
- Implemented and managed document control system, ensuring streamlined operations
- Authored Standard Operating Procedures (SOPs) for laboratory procedures, maintaining high standards of quality and safety
- Conjugated monoclonal antibody to enzymes, assessed raw materials, and developed ELISA assays for clinical immunoassays
- Prepared samples for analysis by performing complex sample preparation tasks
- Recorded and analyzed data to produce reports of results
- Participated in lab meetings and project presentations
- Troubleshot and resolved equipment and process issues
Laboratory Production Consultant
ImmunoChemistry Technologies, LLC
01.2022 - 05.2022
- Played pivotal role in relocating ImmunoChemistry Technologies from Bloomington, MN to Davis, CA
- Provided consulting services to new Laboratory Production Manager, fostering seamless transition
- Collaborated remotely on equipment operation and validation, manufacturing, quality control, and customer communication, ensuring regulatory compliance
- Offered technical support to address operational challenges.
Laboratory Production Manager
ImmunoChemistry Technologies, LLC
03.2014 - 12.2021
- Managed all aspects of laboratory operations, including production, quality assessment, and manufacturing of ELISA solutions, cell viability kits, DNA stains, OEM products, service projects, and ancillary reagents, resulting in $1.5M worth of manufactured products
- Operated and analyzed data from flow cytometry, microplate readers, microscopy, and fluorescence imaging equipment
- Spearheaded verification of laboratory SOPs, effectively training production associates and maintaining regulated testing environment
- Supervised laboratory technicians, ensuring high level of quality
- Optimized production schedules to maximize output and minimize waste
- Managed continuous improvement initiatives to drive gains in quality, flow, and output
- Reviewed manufacturing records for quality adherence
- Served as internal auditor for ISO 9001:2015 (E) certification
- Contributed to R&D projects and manufactured custom products
- Fostered strong relationships with key customers and provided technical support for ELISA solutions and cellular assays.
- Managed procurement of production materials and services, staying within budgetary constraints
- Maintained and calibrated laboratory tools and monitored infrastructure, ensuring proper functioning of equipment and safety systems
- Partnered with leadership on recruiting, hiring and coaching production personnel
- Trained in and implemented emergency response procedures to protect team members and property
- Delivered direct feedback to senior management regarding project visibility and status
- Evaluated employee performance and provided feedback and training as needed
- Coordinated with other departments to align production with customer requirements
- Enforced health and safety protocols to promote safe working environment
- Analyzed production data and prepared reports for senior management
Laboratory Production Associate
ImmunoChemistry Technologies, LLC
07.2013 - 03.2014
- Manufactured, quality-tested, and packaged ELISA solutions and caspase assay kits
- Monitored material storage conditions and managed inventory levels
- Assisted in various R&D tasks.
Education
Bachelor's degree in Biology -
St. Catherine University
Saint Paul, MN05.2012
Skills
- ELISA
- Production Management
- Lyophilization
- Flow cytometry
- Conjugation
- SDS-PAGE
- Cell culture
- Buffer optimization
- Immunoassay Development
- Calibration/Validation
- High-Performance Liquid Chromatography (HPLC)
- ISO 9001:2005 Internal auditing
- GLP/ GMP
- Controlled Document Management (8 years)
- Quality Assurance/ Quality Control
Timeline
Senior Research Associate / Scientist
Mindray
03.2022 - 11.2023
Laboratory Production Consultant
ImmunoChemistry Technologies, LLC
01.2022 - 05.2022
Laboratory Production Manager
ImmunoChemistry Technologies, LLC
03.2014 - 12.2021
Laboratory Production Associate
ImmunoChemistry Technologies, LLC
07.2013 - 03.2014
Bachelor's degree in Biology -
St. Catherine University
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