Principal Material Sciences Engineer

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.