Lyn Watson, PhD adjfo5@r.postjobfree.com 978-***-**** Hampton, NH

Jan 2021

Summary

Accomplished QC Analytical Professional in Biopharma. Lifelong Learner.

Plan and perform method transfers and validations, write protocols reports, and test methods (GMP)

SME for Analytical Project Teams

Write investigations and deviations, troubleshoot methods, write and review sections of PQRs

Collaborate with stakeholders on strategies for protocols, reports, investigations, deviations

Extensive experience in Analytical Science and Technology

Project management, supervising personnel, QC representative to cross-functional team for new raw materials, leadership of analytical project team, and managing manufacturing investigations.

Optimization and validation of test methods for biologics, excipients, in-process samples, process impurities

Wrote analytical sections of CMC filings

Experience and Contributions

Expertise in biopharmaceuticals testing for SISPQ and characterization:

HPLC, UPLC, RP-HPLC, UV/Vis, SEC, CEX, Titer, CE, LC/MS, Maldi-TOF, GC, GC/MS, SDS-Page

Protocol and report writing for method transfers and validations.

Knowledge of USP, EP, JP, FDA requirements for pharmaceuticals.

Substantial contributions to resolve major deviations within cross-functional teams to identify and prioritize activities according to manufacturing schedule.

Wrote filings and regulatory gap analyses on schedule for analytical methods (Japan, Europe, US).

Transfer and validation of QC methods under tight timelines in support of product testing

Skills

Trackwise, LIMS, Microsoft Office Suite, DMS, ELN, Empower, Chromeleon

Met deadlines for overlapping projects and investigations in fast-paced environment with changing priorities to support business and compliance needs.

Works well with cross-functional teams such as investigations and analytical project teams.

Deviations, investigation, and change control writer.

Ability to review and critique complex technical documents as demonstrated by writing and review of validation documents, investigations, retesting plans with rationale, and operating procedures.

Detail oriented team player with ability to listen as well as to develop and promote alternative strategies.

EMPLOYMENT HISTORY

Lonza Biologics (12/2015-Present) QC Scientist I

Pfizer/Wyeth BioPharma, (01/2002 - 02/2015) Senior Scientist II (final)

Shire Pharmaceuticals (07/2011 - 01/2012) Analytical Support Manager

Muro Pharmaceuticals (05/1998 - 01/2002) Chemist II

Professional Development

LinkedIn Learning Career and Soft Skills Development 2020

Activate Spark 2019 Prof Development

EDUCATION

PhD, Boston College, Chemistry, 1990.

BS, University of Massachusetts at Boston, Chemistry, 1984.

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