Steven A. Bartimo
Pasadena
Summary
Biotechnology specialist with a strong background in assay development and regulatory compliance. Expertise includes managing GLP laboratory functions, project leadership for multiple assays, and collaborating across teams to ensure data integrity and quality in clinical development.
Overview
22
22
years of professional experience
Work History
Director, Regulated Bioanalysis
NextCure
Beltsville
01.2022 - Current
- Was instrumental in the organization of the GLP laboratory at NextCure for the GLP testing of clinical samples in support of NextCure’s drug products in clinical testing.
- Authored 30+ SOPs detailing GLP lab functions at NextCure, including assay development, validation, sample testing procedures, equipment maintenance, and Watson LIMS software usage.
- Directed the validation of the Watson LIMS software and the integration of the software with the MSD and Gyrolab instruments.
- Worked as project leader for a total of 9 assays (development, validation and sample analysis) including 3 PK assays, 3 TK and 3 ADA assays.
- Over the past year, I have been the sole member of the GLP lab responsible for assay performance, instrument maintenance, assay planning, data analysis and reporting.
- Managed assay performance, instrument maintenance, assay planning, data analysis, and reporting.
- Collaborated with clinical, research, manufacturing, and quality control teams to support clinical development of drug products.
- Ensured accurate receipt and verification of clinical samples for GLP studies to maintain integrity.
- Received, verified, and maintained all clinical samples for the GLP studies using the Watson LIMS software.
- Collaborated with clinical group and site personnel to resolve discrepancies in sample labels.
- Worked closely with the Quality Assurance group to maintain GLP standards for all laboratory functions.
- Worked to address any QA findings in logbooks, quality forms and analytical assay folders (method, worksheet and raw data).
- In addition, worked with QA to review all project forms (method and analytical plan), data, and final reports.
- Have extensive experience with the following technologies: MSD ECL instruments (SQ120), Gyrolab assays and instruments, BioTek Plate Washers and Envision plate readers.
Associate Scientist III
Catalent
Baltimore
05.2020 - 01.2022
- Perform ELISA and ddPCR analysis of production samples in support of pharmaceutical manufacturing.
- Analyzed and tabulated assay data for performed assays.
- Developed analytical reports and summaries to communicate study findings effectively.
- Executed study activities ensuring compliance with regulatory, GMP, CLIA, protocol, and SOP requirements.
- Maintain experimental records and raw data in a secure way to protect the integrity of the data.
Scientist III
Smithers
Gaithersburg
03.2012 - 04.2020
- Senior scientist in charge of projects for method development, transfer and/or validation of immunoassays in support of Client GLP studies.
- Analyzed and tabulated assay data for method development and validation projects.
- Provided analytical reports and summaries to communicate study results and findings.
- Perform study activities to meet the regulatory, GLP, CLIA, protocol and SOP requirements.
- Maintain experimental records and raw data in a secure way to protect the integrity of the data.
- Perform labeling reactions for the biotinylation and ruthenylation of proteins and antibodies.
- Maintained all assigned laboratory equipment records and updated all calibrations, standardizations, and repairs in a timely manner.
Research Associate III
Wellstat Diagnostics
Gaithersburg
08.2007 - 03.2012
- Led the development of assays for a point of care instrument at Wellstat Diagnostics.
- Designed assays to enable rapid bedside testing for doctors, enhancing patient care.
- Completed feasibility studies for seven assays for use in the point of care instrument.
- Completed feasibility studies for seven assays for use in the point of care instrument.
- Trained laboratory staff on ECL technology, improving proficiency in immunogenicity assays.
- Maintained and validated laboratory equipment.
- Created SOPs and Work Instructions to standardize laboratory procedures, ensuring compliance and consistency.
- Maintained laboratory records and equipment logs as defined by SOPs and GLP standards.
- Contributed to the Wellstat Diagnostics Emergency Responder team.
Research Associate
BioVeris Corporation
Gaithersburg
01.2005 - 07.2007
- Trained in the use of ECL technology in Immunogenicity assays.
- Performed ECL assays in support of clinical trials according to methods and SOPs.
- Conducted development and validation assays for new ECL assay methods.
- Maintained and validated laboratory equipment.
- Created and updated SOPs to ensure compliance with protocols.
- Maintained laboratory records and equipment logs as defined by SOPs and GLP standards.
- Participated in the BioVeris Lab Audit team to conduct internal QA audits.
Education
Master of Science - Biotechnology
Johns Hopkins University
Baltimore, MD05.2002
Bachelor of the Arts - Aquatic Biology
St. Mary’s College of Maryland
Saint Marys City, MD05.1997
Associates Degree - Biology
Anne Arundel Community College
Arnold, MD05.1994
Skills
- GLP compliance
- Watson LIMS
- assay validation
- SOP development
- quality assurance
- regulatory compliance
- Clinical sample management
- data analysis
- project management
- instrument calibration
- attention to detail
- adaptability
Summary Of Experience
Steven has been in the biotechnology industry for 21 years. He has experience in the performance, development, and validation of immunoassays in ELISA, Electrochemiluminescent (ECL) and Gyrolab assay formats. He has developed and validated many assays for the ECL and Gyrolab assay technology. Steven also has experience working under GLP and CLIA regulations.
Timeline
Director, Regulated Bioanalysis
NextCure
01.2022 - Current
Associate Scientist III
Catalent
05.2020 - 01.2022
Scientist III
Smithers
03.2012 - 04.2020
Research Associate III
Wellstat Diagnostics
08.2007 - 03.2012
Research Associate
BioVeris Corporation
01.2005 - 07.2007
Master of Science - Biotechnology
Johns Hopkins University
Bachelor of the Arts - Aquatic Biology
St. Mary’s College of Maryland
Associates Degree - Biology
Anne Arundel Community College