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James Chung

@jameschung

Product Development Program Manager at Impossible Foods who cut validation cycle time by ~70% with a risk-based framework.

United States

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At Impossible Foods, Inc., I directed product development strategy and execution across active R&D programs. I also helped establish a repeatable, risk-based validation framework using Lean Six Sigma/DMAIC principles, reducing cycle time by an estimated ~70% while maintaining quality and safety standards.

As Supervisor, Product Development, R&D at Impossible Foods, Inc., I drove execution for 20+ products from concept to launch and introduced FMEA-based risk management into program governance. I led a cross-functional data management program that delivered a SQL-backed dashboard and reduced query time by ~40%.

Earlier, I managed qualification programs and developed validation protocols across regulated life science and medical-device settings, including work on the Cobas Liat system at Roche Molecular Solutions. At Baxter International, I directed root cause investigations and owned CAPA and ECR/ECO implementation and effectiveness monitoring.

Experience

Work history, roles, and key accomplishments

Manager, Product Development, R&D

Impossible Foods, Inc.

Jul 2025 - Jun 2026 (11 months)

Led product development strategy and execution across all active R&D programs, integrating parallel technical workstreams and resolving competing priorities to ensure on-time delivery. Directed a process improvement initiative that implemented a risk-based validation framework, reducing cycle time by ~70%.

Program Management Product Development R&D Cross functional Leadership Risk Management Lean Six Sigma DMAIC SQL Looker Streamlit Snowflake GCP Dashboarding P&L Forecasting

Supervisor, Product Development, R&D

Impossible Foods, Inc.

Jan 2021 - Jul 2025 (4 years 6 months)

Drove program execution for 20+ products from concept to launch, meeting launch timelines and quality targets. Introduced FMEA-based risk management frameworks and led a cross-functional Data Management Program that reduced query time by ~40%.

Program Management Product Development R&D FMEA Risk Management Lean Six Sigma DMAIC SQL Data Management Team Leadership Cross Training

Validation Engineer II / Client Site Lead

Delta Project Management, Inc.

Aug 2019 - Dec 2020 (1 year 4 months)

Served as primary program owner and site lead across three life science client sites, managing scope, resources, and deliverables for hardware qualification programs. Directed IQ/OQ/PQ protocols and authored engineering documentation under GxP/FDA-regulated systems.

Validation IQ OQ PQ Validation GxP FDA Document Control Eco Stakeholder Management Project Management

Automation Engineer II

Matrix Technologies, Inc.

Jan 2018 - Aug 2019 (1 year 7 months)

Executed qualification and hardware validation protocols for automation and control systems for a global biopharmaceutical client. Authored controls design documentation and executed SAT/FAT commissioning and I/O testing.

Automation Validation IQ OQ PQ Validation GxP FDA FAT SAT Testing Documentation

Systems Engineer I, R&D

Roche Molecular Solutions

Jan 2016 - Dec 2017 (1 year 11 months)

Partnered with Engineering and Assay Development teams to design V&V protocols for the Cobas Liat in vitro diagnostics system. Led hardware and software improvement initiatives that reduced failure rates by ~30%.

Systems Engineering V&V Hardware Software Integration Failure Analysis Process Improvement

Process Investigator, PSTO

Baxter International

Mar 2014 - Dec 2015 (1 year 9 months)

Directed root cause investigations and owned CAPA and ECR/ECO implementation and effectiveness monitoring. Authored FDA-facing reports for product and process deviations under FDA/ISO 13485 regulations.

Root Cause Analysis CAPA ECR FDA ISO 13485 Quality Systems Documentation