Study Lead, Biopharmaceuticals

Thermo Fisher Scientific seeks a Study Lead for its GMP biopharmaceutical laboratory in Middleton, Wisconsin to oversee routine analytical projects, manage client communications, and ensure regulatory compliance. The role involves directing testing activities, interpreting data, preparing scientific reports, and mentoring laboratory staff on established methods.

Responsibilities

• Manage multiple routine projects including release, stability, and quality control testing
• Direct analytical testing, troubleshoot methods, and interpret results using established protocols
• Communicate project status, findings, and deliverables to clients and internal stakeholders
• Prepare and review study protocols, reports, and quality records for accuracy and compliance
• Mentor and train laboratory staff on routine test execution and troubleshooting approaches

Requirements

• Bachelor's degree or equivalent relevant academic or vocational qualification
• Experience managing analytical laboratory projects and routine testing activities
• Knowledge of GMP standards, regulatory guidelines, and data integrity requirements
• Ability to write scientific protocols, reports, and technical documentation
• Strong communication skills for internal and client stakeholder engagement
• Proficiency with laboratory instruments and analytical detection techniques
• Legal authorization to work in the United States without sponsorship