Summary
Overview
Work History
Education
Skills
Timeline
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Valerie Fischetti

Summary

With 20 years of experience in biotech, I've worked in GMP quality control, analytical method development, and quality management. I have worked for both a large pharmaceutical company, as well as startups. My scientific background enables me to understand operational intricacies and enhance process excellence across operations and manufacturing. I focus on data-driven decision-making and am committed to continuous process improvement.

Overview

19
19
years of professional experience

Work History

Senior Quality Manager

Modern Meadow, Inc.
09.2017 - Current
  • Established an effective Quality Management System from the ground up; selection of eQMS, buildout, implementation, trainings and improvements
  • Head of document control; establish policies, creating templates, writing, reviewing, approving SOP’s, working instructions, technical reports, stability reports and datasheets
  • Implemented ISO 9001:2015; formalized processes and quality objectives to meet requirements of the standard
  • Initiated QMS for medical devices; ISO 13485:2016 and 21 CFR Part 820
  • Conducted root cause analysis for process failures, non-conformances, and deviations followed by documenting effective corrective and preventative measures
  • Maintained suppliers, external vendors and customer satisfaction surveys to drive continuous improvement
  • Conducted risk assessments cross-functionally to identify areas to improve and devise mitigation plans
  • Supervised stability studies to determine specifications and shelf-life of final products and in-process intermediates; created stability program, interpret and present data, write protocols and final reports
  • Achieved final product certifications for commercial products made domestically as well as internationally; Halal, Vegan, Non-GMO
  • Responsible for labeling, release, and inventory management for commercial products
  • Assisted in tech transfer documentation and Quality Agreements for external scale up operations
  • Experience managing employees; setting goals, delegating tasks, professional growth skills
  • Self-motivated, with a strong sense of personal responsibility
  • Work effectively in fast-paced, constantly changing environment

Senior Research Associate

Vaxinnate Corp.
10.2010 - 11.2016
  • Method development, optimization and/or qualification and transfer of the following assays: SEC, IEX and RP HPLC/UPLC (Empower), Titer Assay using RP-HPLC, TLR5-Bioassay, cell culture & aseptic techniques, Direct/Capture ELISA, Residual DNA/RNA, HCP ELISA, UV280, BCA, Bradford, pH, LAL Endotoxin Analysis, Silver Stain/Colloidal Blue SDS PAGE and IEF
  • Release and stability testing of Bulk Drug Substance and Drug Product under cGMP conditions
  • Evaluate vaccinations for effectiveness against viral infections such as influenza and dengue,

Quality Control Analyst

ImClone Systems Inc./Eli Lily
07.2005 - 10.2010
  • Provided QC (Biochemistry) support for the commercial production of ERBITUX (monoclonal antibody)
  • Assays performed according to GMP guidelines: DiFi Cell Assay, ELISA, IEF and SDS-PAGE, HPLC and wet chemistry; results reported in LIMS (StarLIMS)
  • Supported regulatory audits (FDA; Canada) and internal audits; knowledge and compliance of ICH guidelines including 21 CFR Parts 210 & 211, ISO 9001 and ICH Q7

Education

Bachelor of Arts - Biology

The College of New Jersey
Trenton, NJ
06.2003

Skills

  • eQMS: QT9, Qualio
  • LIMS: LabVantage
  • Quality Management Systems
  • GMP Quality Control
  • Analytical method development
  • Documentation Control
  • ISO 9001 compliance
  • Change Control Management
  • Analytical test method validation
  • Corrective and Preventive Actions
  • Problem-solving abilities
  • Risk Assessments & Mitigation Plans
  • JMP Statistical Analysis
  • Project Leadership Academy
  • Project Management
  • Mentoring & Team Motivation

Timeline

Senior Quality Manager

Modern Meadow, Inc.
09.2017 - Current

Senior Research Associate

Vaxinnate Corp.
10.2010 - 11.2016

Quality Control Analyst

ImClone Systems Inc./Eli Lily
07.2005 - 10.2010

Bachelor of Arts - Biology

The College of New Jersey

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Valerie Fischetti