Study Lead, Biopharmaceuticals (Onsite – WI)

ThermoFisher Scientific; Town of Middleton (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Study Lead for our GMP Laboratory in Middleton, WI. This fully onsite role requires coordinating routine studies, communicating with clients, and ensuring data quality and regulatory compliance.

The candidate will guide junior staff and manage multiple studies within SOPs. The position emphasizes analytical testing, data interpretation, and collaboration with internal stakeholders.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic qualification
• 5+ years of experience in analytical testing or GMP labs
• Working knowledge of GMP requirements and data integrity
• Proficient with Microsoft Office and data tools

Responsibilities

• Translate project requirements into study design plans and manage timelines.
• Prepare and review routine study protocols, status reports, final study reports, and quality records.
• Communicate updates to clients and internal stakeholders; escalate risks.
• Mentor and train laboratory staff for routine test execution.
• Ensure data integrity and regulatory compliance.

Skills

Data analysis

Oral & written communication

Organizational skills

Problem solving

Confidentiality

Mentoring

Education

Bachelor's degree or equivalent

Tools

PowerBI

Excel

PowerPoint

SharePoint

Teams

Job description

Thermo Fisher Scientific is seeking a Study Lead for our GMP Laboratory in Middleton, WI. This fully onsite role requires coordinating routine studies, communicating with clients, and ensuring data quality and regulatory compliance.

The candidate will guide junior staff and manage multiple studies within SOPs. The position emphasizes analytical testing, data interpretation, and collaboration with internal stakeholders.