Pharma QC Stability & Empower CDS QA Lead

Nancy Duggan

Andover, MA

978-***-**** ********@*******.***

Professional Profile

Quality Control, Quality Assurance, and Stability Scientist with over 20 years of leading teams in the pharmaceutical and biotechnology industry.

Key Accomplishments:

Directly involved in product filings which led to approvals for therapeutics for cancer, hemophilia, and C. difficile, as well as cancer vaccine treatment.

Directly involved in agency inspections, with a strong focus on QC laboratory compliance and product SISPQ. Extensive cGMP experience.

Stability program owner and SME: coordination of testing, impact assessments, and updating stability sections for annual product quality reviews; authoring protocols and reports; directing change controls, deviation investigations, temperature excursions, collaboration on regulatory responses, JMP statistical analyses.

Highly skilled at troubleshooting analytical methods and instrumentation. Over 20 years’ experience with chromatography instrumentation and software, including Empower CDS validation. Empower lab administrator and qualified trainer.

Labware LIMS URS collaborator, OQ/PQ tester, LIMS qualified trainer, and LIMS business system owner (BSO) and business process owner (BPO) at Sanofi.

Direct experience working for contract test laboratory (Boston Analytical, now BA Sciences) and contract manufacturer (Johnson Matthey, now Veranova).

Years of experience with various QMS including Veeva, TrackWise, Master Control, CatsWeb, Phenix (Sanofi).

Equipment/instrument expertise in HPLC, UPLC, GC, FTIR, UV-Vis, AA, KF.

Work Experience

LANTHEUS, Billerica, MA 03/2024-03/2026

Leading radiopharmaceutical-focused company, developing, manufacturing and commercialization of pioneering diagnostic and therapeutic products.

Senior Quality Scientist, Quality Control Labs and Services

Empower Chromatography Data System (CDS) business system administrator and trainer.

Implementation of Empower CDS, integration with Laboratory Information Management Software (LIMS, LabVantage).

Stability Program SME including APQR for multiple products. Revision/owner of stability program document. SRB (Stability Review Board) member/presenter of annual product data and authoring update memos, reviewing and verifying all data for Definity product.

Updated quarterly and annual metrics for QC.

AA Method transfers (3) to contract labs.

SERES THERAPEUTICS, Waltham, MA 01/2022 – 12/2023

Biotechnology company working to revolutionize treatment for a wide range of diseases by modulating the function of the human microbiome.

QC Manager/Principal Specialist, Quality Control Compliance

Reported to Executive Director of Quality Control.

Directly involved in BLA filing, which gained FDA approval for the first microbiome therapeutic for C. diff (2023).

Generated over 100 certificates of analysis (right first time) for commercial product and clinical expiry extensions in 2023.

Generated and updated commercial and clinical specifications. Oversaw change controls for product specification updates.

Subject matter expert for Seres stability program. Authored stability program and oversaw all stability deviations, CAPAs, and continuous improvements. Oversaw stability studies, collaborated on and authored stability section, and updated all stability data for drug substance and drug product lots in BLA.

Owned and improved procedures for certificates of analysis, specifications, and stability program.

SANOFI, Waltham, MA 09/2019 – 01/2022

International supplier of injectable polio vaccine and the first influenza, meningitis, and rabies vaccines, with portfolio of vaccines that protect over half a billion people worldwide.

Manager, Quality Control and Stability, Quality Assurance Technical Services

Reported to the Head of Quality Assurance Technical Services

Updated stability sections for annual product quality report.

Managed all release and stability testing at contract labs in Europe and US for commercial hemophilia products.

Labware LIMS qualified trainer, business system owner, and process owner.

Validated all test results in LIMS for lot release of hemophilia commercial products.

Senior Stability Associate, Quality Assurance Technical Services

Reported to the Head of Quality Assurance Technical Services

Updated stability sections for annual product quality report.

Supported operational and technical aspects of clinical and commercial drug substances, drug product, reference standard, and diluent GMP stability programs.

LIMS qualified trainer, LIMS business system owner, and LIMS process owner.

BIOVERATIV, A SANOFI COMPANY, Waltham, MA (started as a contractor 6/2018) 06/2018 – 09/2019

Multinational biotechnology company specializing in discovery, development, and delivery of therapies for the treatment of hemophilia. A spin-off of Biogen acquired by Sanofi.

Stability Specialist, Quality Assurance Technical Services

Reported to Associate Director of Stability

Supported operational and technical aspects of clinical and commercial drug substances, drug product, reference standard, diluent, and placebo GMP stability programs.

Transferred all stability samples for hemophilia products from Biogen, NC, to PPD Laboratories, Ireland.

BOSTON ANALYTICAL, Salem, NH (started as a consultant) 09/2015 – 06/2018

Analytical testing services for the CMC (chemistry, manufacturing, and controls) parameters involved in drug development and release testing.

Quality Consultant, Senior Chemist

Reported to Quality Director

Administrator and trainer of Empower software for over 65 users.

Oversaw training and implementation of Empower chromatography data software.

Generated over 100 projects in Empower for analysts.

Foundational Experience

Quality Control Manager, AGENUS (formerly ANTIGENICS), Lexington, MA

Quality Control Supervisor, AGENUS (formerly ANTIGENICS), Lexington, MA

Quality Control Supervisor, WYETH BIOPHARMA, Andover, MA

Quality Control Associate Scientist, Stability, WYETH BIOPHARMA, Andover

Education

Master of Science, Environmental Engineering/Technology, University of Massachusetts, Lowell, MA

Bachelor of Science, Chemistry, Merrimack College, North Andover, MA

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