Principal Engineer, Pharmaceutical Development

Principal Engineer leading pharmaceutical development for small-molecule drug products at late-stage clinical and commercial programs. Responsible for process development, CDMO scale-up, technology transfer, and regulatory compliance to support manufacturing operations and patient access.

Responsibilities

• Lead engineering and process optimization for drug product manufacturing and CDMO scale-up activities
• Manage equipment engineering and operations at drug product CDMOs including troubleshooting and process validation
• Coordinate across CDMOs, QA, Chemical Development, and Supply Chain for timely lot manufacture and release
• Write and review CMC sections for regulatory filings including INDs and NDAs
• Provide on-site support and performance monitoring of manufacturing KPIs across facilities

Requirements

• Ph.D. chemical engineering or related field with 8+ years late-phase small-molecule drug product development
• Extensive GMP oral solid dose manufacturing experience (spray drying, tableting, encapsulation, scale-up, validation)
• Proven third-party CDMO management including tech transfer, QBD, DOE studies, clinical and commercial production
• Deep knowledge of cGMP, ICH, FDA, and EMA guidelines and regulatory requirements
• Strong internal and external collaboration and communication skills
• Ability to travel up to 25% and work in fast-paced, multitasking environment

Compensation: $195,300 - $222,900