GMP Study Lead — Lab Projects & Data Management

RXinsider LTD.; Town of Middleton (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific in Middleton, WI is seeking a Study Lead to manage multiple routine projects (release, stability, quality control), coordinate with clients and internal stakeholders, and deliver on-time studies. You will review data, write reports and protocols, and maintain quality records while ensuring GMP adherence.

Strong analytical, communication, and mentoring abilities are essential to oversee testing with established methods and instruments, escalating non-routine issues as

Qualifications

• Bachelor’s degree or equivalent and relevant formal academic qualification.
• 5+ years experience in analytical testing or pharmaceutical lab roles.
• Strong data analysis, trend identification, and reporting skills.
• Working knowledge of GMP and data integrity principles.
• Proficient in Microsoft Office and data visualization tools.

Responsibilities

• The Study Lead is responsible for managing multiple routine projects (release, stability, and quality control), communicating updates to clients and stakeholders.
• Reviewing and evaluating data, writing scientific reports and protocols, and maintaining quality records.
• Ensure adherence to regulatory guidelines and SOPs; provide guidance to junior staff.
• Direct and oversee testing with established methods using analytical instruments and detection techniques.
• Escalate non-routine or complex issues to senior staff and provide technical direction as needed.
• Deliver timely and accurate study outputs while maintaining data integrity and client expectations.

Skills

Analytical testing

Data analysis

Microsoft Excel

Power BI

Laboratory techniques

GMP knowledge

Scientific writing

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Data acquisition software

Job description

Thermo Fisher Scientific in Middleton, WI is seeking a Study Lead to manage multiple routine projects (release, stability, quality control), coordinate with clients and internal stakeholders, and deliver on-time studies. You will review data, write reports and protocols, and maintain quality records while ensuring GMP adherence.

Strong analytical, communication, and mentoring abilities are essential to oversee testing with established methods and instruments, escalating non-routine issues as