Biopharma Study Lead - Onsite GMP Lab

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

Job summary

Thermo Fisher Scientific seeks a Study Lead for our GMP Laboratory in Middleton, WI. This onsite role oversees routine projects (release, stability, QC), communicates with clients, and ensures data integrity under SOPs and regulatory guidelines.

The candidate will write reports, review data, guide staff, and support continuous improvements while coordinating with internal stakeholders and senior staff.

Qualifications

• Bachelor's degree or equivalent required.
• Experience with routine analytical testing and data interpretation.
• Knowledge of GMP and data integrity principles.
• Ability to manage multiple projects and communicate with clients.

Responsibilities

• Translate project requirements into study design plans and manage timelines.
• Provide guidance and mentoring to laboratory staff.
• Prepare routine study protocols and final reports.
• Collate and evaluate data to ensure accuracy and compliance.
• Escalate non-routine issues to senior staff.

Skills

Data analysis

Project management

Communication

GMP knowledge

Education

Bachelor's degree or equivalent

Tools

PowerBI

Excel

Word

PowerPoint

SharePoint

Teams

Job description

Thermo Fisher Scientific seeks a Study Lead for our GMP Laboratory in Middleton, WI. This onsite role oversees routine projects (release, stability, QC), communicates with clients, and ensures data integrity under SOPs and regulatory guidelines.

The candidate will write reports, review data, guide staff, and support continuous improvements while coordinating with internal stakeholders and senior staff.