Senior Study Lead - Biopharmaceuticals (GMP & Data-Driven)

ThermoFisher Scientific; Town of Middleton (WI); On-site; USD 110,000 - 170,000; Full time

Job summary

Thermo Fisher Scientific in Middleton, Wisconsin seeks a Senior Study Lead to oversee large-scale routine projects in biopharmaceuticals. You will manage studies, ensure regulatory compliance, and mentor junior staff while coordinating with clients and internal teams.

You will draft and review protocols, reports, and quality records, drive continuous improvement, and ensure study quality and data integrity across programs in a fast-paced environment.

Qualifications

• Experience leading large, complex laboratory programs.
• Strong knowledge of GMP, FDA guidelines, and QA practices.
• Ability to draft protocols, reports, and QC documentation.

Responsibilities

• Oversee multiple routine projects (release, stability, QC) and communicate progress to clients and leadership.
• Design and manage study plans and program strategies with cross-functional teams.
• Identify and implement solutions to technical challenges and improve lab processes.
• Mentor Study Lead team members and foster audit readiness.
• Lead audits, CAPAs, and continuous improvement efforts.
• Review client deliverables to ensure quality and regulatory compliance.

Skills

Leadership

Regulatory compliance

Project management

Quality systems

Data analysis

Education

Bachelor's degree or equivalent

Tools

LIMS

MS Office

Power BI

Job description

Thermo Fisher Scientific in Middleton, Wisconsin seeks a Senior Study Lead to oversee large-scale routine projects in biopharmaceuticals. You will manage studies, ensure regulatory compliance, and mentor junior staff while coordinating with clients and internal teams.

You will draft and review protocols, reports, and quality records, drive continuous improvement, and ensure study quality and data integrity across programs in a fast-paced environment.