Jacqueline Gunther

---

Process Manufacturing Expert & Technical Writer | Biopharmaceutical Operations Specialist

Jacqueline Gunther is a versatile process manufacturing expert and technical writer with over 22 years of distinguished experience in biopharmaceutical operations and cGMP documentation. Throughout her career, she has established herself as a leading authority in regulatory compliance, process optimization, and technical documentation across multiple Fortune 500 pharmaceutical companies.

Ms. Gunther specializes in authoring critical regulatory documents including Batch Records, SOPs, Work Instructions, Validation Protocols, and training materials while ensuring strict compliance with FDA, EMA, and ICH regulations. Her expertise spans the complete biopharmaceutical manufacturing lifecycle, from process development through commercial production.

Core Competencies:

• GxP Documentation: Policies, SOPs, Work Instructions, Batch Records, Validation Protocols
• Regulatory Compliance: FDA, EMA, ICH Guidelines, Data Integrity (ALCOA+)
• Digital Systems Integration: Delta V Automation, Operation Execution Systems, Veeva, Trackwise
• Validation & Quality Systems: Risk Assessments, Operational and Process Qualification, Deviation/CAPA
• Process Optimization: Lean Manufacturing, Right First Time Execution, Cost Reduction Initiatives
• Continuous Improvement: Batch Record Error Reduction, Automation of Documentation Processes

Current Role (2022-Present): As an Independent Contractor through RevZero, Inc., Ms. Gunther is currently establishing standardized GxP document hierarchies and authoring frameworks for major pharmaceutical companies including Tolmar, Inc. and Leiters Health. Her work focuses on creating consistent documentation standards that improve compliance, reduce errors, and enhance manufacturing capabilities.

Leadership in Digital Transformation: At ThermoFisher Scientific (2021-2022), she partnered with Process Development and Automation teams to design a revolutionary Operation Execution System (OES), leading to the creation of the industry's first paperless facility in their Bioprocessing Collaboration Center. She designed and authored completely new upstream and downstream operation procedures optimized for digital execution.

Global Impact During COVID-19: As a Validation Engineer at AstraZeneca (2019-2021), Ms. Gunther was a key global technical operations team member responsible for the accelerated shipment qualification of the COVID-19 vaccine. She authored global validation procedures and risk assessments that enabled timely and cGMP-compliant deliveries worldwide during the critical early phases of the pandemic.

Process Innovation & Cost Savings: Her tenure at Genentech (2005-2013) exemplifies her ability to drive transformational change. She implemented a new product introduction business process that reduced campaign readiness activities from 5.5 months to 2.5 months, decreased document management activities by 75%, and generated total cost savings of $940,000. Additionally, she designed and validated an automation system for electronic batch record generation.

Ms. Gunther's expertise has been recognized through:

• Published Research: Co-authored "Freeze Bulk Bags: A Case Study in Disposables Implementation" in Biopharm (2009)
• Process Excellence: Contributed to Genentech Oceanside's achievement of Oliver Wight's Class A Business Excellence status through Lean Manufacturing implementation
• Innovation Leadership: Led multiple automation and digitization initiatives that became industry best practices

• B.S. Biology - Mary Washington College, Fredericksburg, VA (2002)

Throughout her career, Ms. Gunther has demonstrated an exceptional ability to translate complex technical knowledge into clear, audit-ready documentation that drives efficiency, compliance, and knowledge transfer across cross-functional teams. Her work spans quality assurance, manufacturing, engineering, R&D, facilities, and automation departments.

Her contributions have consistently focused on:

• Risk Mitigation: Developing documentation strategies that prevent regulatory issues
• Operational Excellence: Implementing systems that ensure "Right First Time" execution
• Knowledge Transfer: Creating comprehensive training materials and procedures
• Technology Integration: Leading digital transformation initiatives in manufacturing

Ms. Gunther has provided consulting and full-time expertise to industry leaders including:

• AstraZeneca
• Genentech (Roche Group)
• ThermoFisher Scientific
• BioMarin Pharmaceutical
• MedImmune
• Biogen Idec
• Tolmar, Inc.
• Leiters Health

With her unique combination of deep technical knowledge, regulatory expertise, and proven track record of driving operational improvements, Jacqueline Gunther continues to be a sought-after expert in biopharmaceutical manufacturing and technical documentation.

Ms. Gunther is available for consulting engagements focused on GxP documentation, process optimization, and digital transformation initiatives in biopharmaceutical manufacturing.