CMC Internal Operations Specialist

Responsibilities

• Support material management for clinical production including shipping, receiving, procurement, and inventory
• Assist with facilities and EHS activities including maintenance documentation and hazard waste compliance
• Perform small and large scale (0-200L) solution production and formulation preparation
• Support upstream and downstream process development and manufacturing operations (GMP & non-GMP)
• Collaborate with CMC, Quality, Supply Chain, and Clinical teams to ensure manufacturing alignment
• Debottleneck and rationalize operational processes to optimize efficiency

Requirements

• BS/BA degree
• 0-3 years of experience in the Biotech Industry preferred
• Mathematical aptitude for solution preparation and calculations
• Experience in biological process development or manufacturing
• Ability to lift a minimum of 25 pounds and operate pallet jacks
• Willingness to complete EHS and Wastewater Management certifications

Preferred Qualifications

• Experience in a GMP regulated environment
• Proficiency in Good Documentation Practices (GDP)

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.