Principal Material Sciences Engineer
Regeneron
August 25, 2026
On-site
East Greenbush, NY
Operations
Discover Your Role
- Applies materials expertise across polymer science, physics, metallurgy, ceramics, and composites to drive design, development, and life-cycle management in biomedical/biopharmaceutical environments.
- Provides technical support, guidance, and risk assessment across technology transfer, design transfer, process control strategy, process validation lifecycle, and post-commercialization activities.
- Analyzes data from development through late-stage characterization and at-scale manufacturing history to drive insights into process performance and control.
- Develops and executes process controls and validation strategies, including support for lab 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; 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.
This Role Requires
- BS in Materials Science Engineering (or related engineering) and 8+ years of relevant experience.
- M.S. or Ph.D. preferred.
- Background in aseptic processing, drug substance development, drug product development, and/or combination product development.
- Applies materials expertise across polymer science, physics, metallurgy, ceramics, and composites to drive design, development, and life-cycle management in biomedical/biopharmaceutical environments.
- Provides technical support, guidance, and risk assessment across technology transfer, design transfer, process control strategy, process validation lifecycle, and post-commercialization activities.
- Analyzes data from development through late-stage characterization and at-scale manufacturing history to drive insights into process performance and control.
- Develops and executes process controls and validation strategies, including support for lab 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; 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.
This Role Requires
- BS in Materials Science Engineering (or related engineering) and 8+ years of relevant experience.
- M.S. or Ph.D. preferred.
- Background in aseptic processing, drug substance development, drug product development, and/or combination product development.