Lead Raw Material Qualification Scientist

Insight Global; Lansing (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global in Lansing, MI is seeking a Raw Material Qualification Consultant to lead qualification and validation of dehydrated culture media and other microbiology products.

You will manage qualification projects from experimental design to data analysis, work cross-functionally with Quality, Operations, Procurement, Product Development and suppliers, and develop validation strategies while ensuring cGMP and data integrity.

Qualifications

• 5+ years of relevant experience in research, product engineering, quality, manufacturing, validation, or a related technical environment.
• Experience with experimental design, validation, technical documentation, and scientific data interpretation.
• Ability to independently manage multiple technical projects and drive them through completion.

Responsibilities

• Lead raw material qualification and equivalency studies for new, alternate, changed, or at-risk raw materials.
• Develop validation strategies, experimental plans, acceptance criteria, sampling approaches, and testing sequences.
• Conduct and oversee microbiological and experimental testing to understand the impact of raw material variability.
• Manage multiple qualification projects, timelines, laboratory resources, documentation, and stakeholder communication.
• Analyze technical data and use statistical methods to identify trends, atypical results, and testing gaps.
• Prepare validation protocols, technical reports, summaries, and recommendations.
• Partner with Quality, Operations, Procurement, Product Development, Manufacturing Engineering, and suppliers.
• Lead troubleshooting and root cause analysis related to unexpected qualification results or raw material performance.
• Ensure work complies with applicable procedures, cGMP, ISO, data-integrity, safety, and environmental requirements.
• Support change management, supplier changes, process improvements, and supply-continuity initiatives.

Skills

Project management

Analytical thinking

Strong communication

Statistical analysis

Education

Bachelor's in Biochemistry or related

Tools

Quality systems

Job description

Insight Global in Lansing, MI is seeking a Raw Material Qualification Consultant to lead qualification and validation of dehydrated culture media and other microbiology products.

You will manage qualification projects from experimental design to data analysis, work cross-functionally with Quality, Operations, Procurement, Product Development and suppliers, and develop validation strategies while ensuring cGMP and data integrity.