Senior Scientist, R&D Design Transfer & Product Development

📋 Description

• Plan and execute process validations (IQ/OQ/PQ) and stability studies
• Support test method development and validation (TMV)
• Lead Risk Management activities including FMEAs
• Maintain Design History Files (DHF) and Device Master Records (DMR)
• Lead change control activities for on-market products
• Investigate deviations and implement CAPA actions

🎯 Requirements

• PhD in Molecular Biology or related field with 4+ years experience
• Hands-on expertise in NGS workflows and DNA/RNA extraction
• Experience with PCR, qPCR, and multiplex PCR techniques
• Ability to design and execute experiments independently
• Knowledge of FDA, ISO 13485, and CLSI standards
• Experience with statistical software such as JMP

🎁 Benefits

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Free genetic testing for employees and family