Raw Materials Scientist

Immediate hiring for Raw Materials Scientist in Indianapolis IN

Overview

A leading pharmaceutical company is seeking a Raw Materials Scientist to support Gene Therapy programs. This role will focus on leading raw material tech transfer activities from external manufacturers to onsite production, ensuring manufacturing readiness and compliance.

Key Responsibilities

• Lead and execute raw materials tech transfer activities
• Manage raw materials for Gene Therapy manufacturing programs
• Support AAV manufacturing, process validation, and batch execution
• Provide hands-on technical support during initial production runs
• Work with mammalian cell culture and viral vectors (HEK293, SF9)
• Perform compendial testing (USP) and related documentation
• Collaborate with Supplier Quality and QC teams
• Draft risk assessments and ensure data integrity compliance
• Support extractables and leachables activities for single-use materials (e.g., vials)
• Manage documentation and cross-functional meetings

Required Experience

• Gene Therapy and AAV manufacturing
• Raw materials management and tech transfer
• Mammalian cell culture (HEK293, SF9)
• USP compendial testing
• Process validation and batch support
• Supplier quality interaction
• Extractables & Leachables experience