Principal Process Characterization & Technology Engineer

About the role

Join our Drug Product Process Sciences team as a Principal Process Characterization & Technology Engineer. This role focuses on material science and provides technical support to manufacturing, quality, combination products, formulations, and CMC Regulatory for manufacturing processes.

Responsibilities

• Applies materials expertise across polymer science, physics, metallurgy, ceramics, and composites, connecting structure, processing, properties, and performance to drive design, development, and life-cycle management in biomedical or biopharmaceutical environments.
• Provides technical support, guidance, and risk assessment related to materials science across technology transfer, design transfer, process control strategy, process validation lifecycle, and post-commercialization activities.
• Analyzes data and information from development through late-stage characterization and at-scale manufacturing history using statistics, engineering principles, and other techniques to drive insights into process performance and control.
• Develops and executes process controls and validation strategies, including support for laboratory and at-scale studies for process characterization and validation.
• Liaises with cross-functional departments (Combination Products, Manufacturing, Quality Control, Formulation Development, Advanced Therapies, Quality Assurance, and CMC Regulatory) to support process lifecycle management.
• Authors protocols, reports, and technical documents with conclusions grounded in process and product knowledge, ensuring SOPs, policies, and validation plans align with industry/regulatory expectations (e.g., ICH guidelines).
• Supports audits/inspections and contributes to CMC sections of regulatory submissions as needed.

Requirements

• BS in Materials Science Engineering or related Engineering field and 8+ years of relevant experience
• M.S. or Ph.D. preferred

Qualifications

• Background in aseptic processing, drug substance development, drug product development, combination product development

Skills

• Materials Science
• Process Characterization
• Validation Strategies
• Statistical Analysis
• Engineering Principles

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (e.g. medical, dental, vision, life and disability)
• Paid time off
• Family support benefits

Pay

$92,200.00 - $150,600.00 annually

Schedule

Monday-Friday, 8am-4:30pm