Biopharma Study Lead - GMP Lab (Onsite)

ThermoFisher Scientific; Town of Middleton (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a passionate Study Lead for the Biopharmaceuticals department in Middleton, WI. This fully onsite role involves managing multiple routine projects, interfacing with clients and internal stakeholders, and ensuring timely, accurate study outputs.

Candidates should have a Bachelor's degree or equivalent and substantial GMP know‑how. The role emphasizes data integrity, regulatory compliance, and scientific reporting.

Qualifications

• Knowledge of routine analytical testing and GMP.
• Strong organizational and communication skills.
• Ability to train and mentor staff; focus on data integrity.

Responsibilities

• Collaborate with internal stakeholders to translate project requirements into study design plans and manage timelines.
• Provide guidance, resources, and training to laboratory staff for routine test execution.
• Prepare and review study protocols, status reports, and final study reports.
• Monitor SOPs and regulatory standards; escalate issues as needed.
• Support continuous improvement and risk mitigation strategies.

Skills

GMP knowledge

Data integrity

Analytical testing

Microsoft Office

Scientific writing

Education

Bachelor's degree or equivalent

Tools

PowerBI

Excel

Job description

Thermo Fisher Scientific is seeking a passionate Study Lead for the Biopharmaceuticals department in Middleton, WI. This fully onsite role involves managing multiple routine projects, interfacing with clients and internal stakeholders, and ensuring timely, accurate study outputs.

Candidates should have a Bachelor's degree or equivalent and substantial GMP know‑how. The role emphasizes data integrity, regulatory compliance, and scientific reporting.