Kate Nardini Email & Phone Number

Philadelphia, Pennsylvania, United States

Lansdale, Pennsylvania, United States

• Senior Scientist, Critical Reagents Lead, Bioprocess R&D (BPR&D) (2014-present)
• Manage all Critical Reagents stored at outsourced storage vendor, Eurofins Lancaster Laboratories, Inc. (ELLI)
• Prepare all necessary documentation/shipments for reagent storage at and retrieval requests from ELLI
• Maintaining control of reagent inventories for 11 Programs, 380 studies, over 50,000 samples
• Act as main liaison between ELLI and Merck lab and operations staff
• Coordinate and review all Critical Reagent Technical Summary documents

• Provided Equipment Validation Support for Analytical Labs (including Maintenance, Training and Safety) & provide System Development Life Cycle (SDLC) training and awareness to analytical areas. Collaborated with Global.
• Maintained the Master Equipment List for Analytical areas and perform quarterly reviews and updates to ensure accuracy and compliance for over 25 analytical laboratories.
• Reviewed all analytical equipment change control documentation for accuracy and completeness per cGMP standards, ensured PM plans were accurate and all maintenance was completed before change control close out.
• Collaborated with equipment shop and maintenance vendors, including LAMP (Laboratory Asset Management Program), ensuring that any instrument Out of Calibration/Tolerance findings are properly reported, documented.
• Ensured that all service timelines were met and any service and facility issues were remediated.
• Provided support for internal and external inspections, audits, and remediation of observations or gaps identified. Collaborated with Quality to resolve inspection observations and collaborated with analysts to.

Review notebook documentation to support regulatory submissions and/or regulatory filings including: analytical raw data, notebook entries, and data reporting memos for clinical product release testing, stability testing, in-process testing of reportable lots, manufacturing facility validation and assay validation. Ensure proper analytical, control and.

Review laboratory and clinical data, monitor and report Adverse Events. Establish timelines with field monitors to ensure completion of critical time points. Support and assist physicians in the planning, execution and control of clinical program. Manage clinical trial by establishing and maintaining rapport with study sites, internal and external.

Ba, Biochemistry

Activities and Societies: Sigma Zeta Math and Science Honor Society, Immaculata College Honor Society

B.A. Biology-Chemistry, Biology, General