Jeffrey Bartlett
Walpole
Summary
A self-motivated, creative solid team player with excellent organizational and communication skills derived from over 30 years of diverse FTE and Contractual Analytical, QA and Validation roles. These roles were based in pharmaceutical, medical device and polymer facilities supporting all Phases of API, DS, DP and Biologics development.
Tech-savvy innovator with hands-on experience in emerging technologies and passion for continuous improvement. Skilled in identifying opportunities for technological enhancements and implementing effective solutions. Adept at leveraging new tools and methods to solve problems and enhance productivity. Excels in adapting to fast-paced environments and driving technological advancements.
Overview
40
40
years of professional experience
Work History
Senior QA Specialist
Moderna
04.2023 - 03.2025
- Responsible for Deviations, Change Controls supporting Phase 3 Clinical trials
QA Senior Technical Reviewer
Cambrex
10.2018 - 01.2023
- Company Overview: (CDMO)
- Provided QA support for all BioPharm Client Projects centered on developing Biologics & Viral Immunotherapies
- Reviewed bioassay data for accuracy and completeness as approving Protocols, MVs, SOPs, TMs and Specifications
- Performed QA Final Approval releasing the reviewed Data Packs, Stability Reports and CoAs
- Assisted CSV with FDA 21 CFR Part 11 implementation on qPCR, Multi-mode Plate Readers, ChemiDoc and HPLC-MS instruments
- (CDMO)
Equipment Validation (Contract w/Softworld)
Brammer Bio
12.2017 - 06.2018
- Company Overview: (CDMO)
- Set-up QC Lab instrumentation for supporting Phase 3 Viral Vector Mfg
- Per USP
- Authored Risk Assessments, URS, VPs, and test scripts
- Executed IQ/OQ/PQ for TOC, qPCR, HPLCs, Multi-mode Plate Readers, Balances, pH instruments
- Performed CSV for Data Integrity and FDA 21 CFR Part 11 implementation
- (CDMO)
Validation Lead III (Contract w/ PRO Unlimited)
Sanofi Pasteur
03.2015 - 03.2017
- Drafted Qualification Summary Reports assessed Supplier Change Notifications and supported Upstream/Downstream Process Validation projects for vaccine production
- Authored SUS and E&L Qualifications for all components used to mfg
- Vaccines encompassing risk assessments, study protocols, data collection and summary reports
Senior Scientist
ENCO Pharmaceutical Development Inc.
02.2013 - 02.2015
- Company Overview: (CRO)
- Team Lead for multiple client projects responsible for small/large molecule analytical method development and validation support
- Conducted CMO analytical method transfer as well as stability testing support
- Conducted equipment installations, drafted IQ/OQ/PQ documents
- (CRO)
CQA Data Reviewer (Contract)
Hospira
11.2011 - 08.2012
- Participated in reducing the backlog of unreleased batch records from 800 to 400 within the first 3 months
- Conducted real time data review, assessed completeness and accuracy of compiled data to ensure compliance with SOPs
Chemist III
Boston Scientific Corporation
03.2006 - 04.2010
Chemist (Contract)
Metabolix
05.2005 - 10.2005
QC Chemist (Contract)
Genzyme
04.2005 - 05.2005
QC Chemist (Contract)
Bristol-Myer-Squibb Imaging
09.2004 - 01.2005
Chemist (Contract)
Metabolix
05.2004 - 07.2004
Laboratory Manager
Theseus Imaging
12.2002 - 04.2004
Analytical Chemist
Berlex Labs (Bayer HealthCare)
05.2001 - 12.2002
Analytical Chemist
Globe Mfg. Corp.
08.2000 - 04.2001
Analytical Chemist (Contract)
Sepracor Inc.
01.1999 - 01.2000
Analytical Chemist (Contract)
Boston Scientific
01.1999 - 01.2000
Technical Manager
Plastic Services, Inc.
01.1998 - 01.1999
Product Development Chemist
Nyacol Nano Technologies
01.1996 - 01.1998
Chemist (Contract)
Polymer Technology (Bausch + Lomb)
01.1994 - 01.1995
Quality Control Chemist
Cohesive Biotechnologies
01.1994 - 01.1995
Chemist
Telor Ophthalmic Pharmaceuticals
01.1993 - 01.1994
Associate Chemist
Alko Diagnostics Corp.
01.1992 - 01.1993
Chemist/ Technician
NOVA Chemicals
01.1985 - 01.1992
Education
B.Sc. - Chemistry
Fitchburg State University
Fitchburg, MA01.1994
Skills
- Root cause analysis
- Problem solving
- Compliance standards
- Product quality
- Documentation and reporting
- Regulatory compliance
- Risk management
- Team collaboration
- Detail-oriented
- Quality improvements
- Quality management systems
- Data analysis
Publications
Colloidal Antimony Pentoxide in Flame Retarded ABS, Flame Retardant Chemicals Association Conference, 03/97
Timeline
Senior QA Specialist
Moderna
04.2023 - 03.2025
QA Senior Technical Reviewer
Cambrex
10.2018 - 01.2023
Equipment Validation (Contract w/Softworld)
Brammer Bio
12.2017 - 06.2018
Validation Lead III (Contract w/ PRO Unlimited)
Sanofi Pasteur
03.2015 - 03.2017
Senior Scientist
ENCO Pharmaceutical Development Inc.
02.2013 - 02.2015
CQA Data Reviewer (Contract)
Hospira
11.2011 - 08.2012
Chemist III
Boston Scientific Corporation
03.2006 - 04.2010
Chemist (Contract)
Metabolix
05.2005 - 10.2005
QC Chemist (Contract)
Genzyme
04.2005 - 05.2005
QC Chemist (Contract)
Bristol-Myer-Squibb Imaging
09.2004 - 01.2005
Chemist (Contract)
Metabolix
05.2004 - 07.2004
Laboratory Manager
Theseus Imaging
12.2002 - 04.2004
Analytical Chemist
Berlex Labs (Bayer HealthCare)
05.2001 - 12.2002
Analytical Chemist
Globe Mfg. Corp.
08.2000 - 04.2001
Analytical Chemist (Contract)
Sepracor Inc.
01.1999 - 01.2000
Analytical Chemist (Contract)
Boston Scientific
01.1999 - 01.2000
Technical Manager
Plastic Services, Inc.
01.1998 - 01.1999
Product Development Chemist
Nyacol Nano Technologies
01.1996 - 01.1998
Chemist (Contract)
Polymer Technology (Bausch + Lomb)
01.1994 - 01.1995
Quality Control Chemist
Cohesive Biotechnologies
01.1994 - 01.1995
Chemist
Telor Ophthalmic Pharmaceuticals
01.1993 - 01.1994
Associate Chemist
Alko Diagnostics Corp.
01.1992 - 01.1993
Chemist/ Technician
NOVA Chemicals
01.1985 - 01.1992
B.Sc. - Chemistry
Fitchburg State University
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