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 • Manage MIDAS review and approval workflows for all critical reagent documents• Create and revise stability study protocols for all critical reagents on stability • Issue re-evaluation dating for all critical reagents for in-house and external analytical use • Create and revise all relevant standard operating procedures including new critical reagent workflow and SOP redesign.• Effectively communicate with analysts, Quality, external vendors and ELLI representatives to meet critical program timelines.

•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 Quality to ensure analytical areas understand the need for SDLC training and equipment validation. Liaised between analysts and Quality to complete validation of instruments and qualification of Controlled Temperature Units. •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, investigated and closed out in a complete and timely manner as per SOP requirements. •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 identify and close gaps.•Created/revised relevant SOPs and completed all required departmental SOP training

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 standard operating procedures are followed, materials used are appropriately referenced, dilutions and calculations are performed correctly, transcriptions are accurate, supporting documentation is attached or referenced and reported results are verifiable and are GMP and 21CFR Part 11 compliant. Ensure that clinical materials and clinical dating documentation timelines are upheld and maintained. Provide group and individual training on notebook related SOPs for new staff and refresher training for current analysts. Assist with development and roll-out of new electronic notebook systems and online data repositories

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 customers. Handle Clinical Study Agreement and budget issues. Clinical sample data collection, tracking and organization including PBMC, serum, and whole blood samples for up to 50 subjects daily. Involved with strategic planning committee to develop new ideas for sample isolation, storage and shipping and to keep present procedures running effectively for clinical assays. Resolution of clinical sample discrepancies ranging from sample packaging issues to poor cell yield and quality issues

Ba, Biochemistry

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

B.A. Biology-Chemistry, Biology, General