Principal Material Sciences Engineer

Regeneron Pharmaceuticals•Valley, AL

9d•$92,200 - $150,600•Onsite

About The Position

Regeneron is seeking a Principal Material Sciences Engineer to join their Drug Product Process Sciences team. This is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. In this partially lab-based role, the engineer will focus on material science and provide technical support to manufacturing, quality, combination products, formulations, and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

Requirements

BS in Materials Science Engineering or related Engineering field and 8+ years of relevant experience.

Nice To Haves

M.S. or Ph.D. preferred.
A background in aseptic processing, drug substance development, drug product development, combination product development.

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.
Applies engineering principles to develop and execute 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, and ensures 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.