Senior Study Lead, Cell Lab — Data & Compliance

ThermoFisher Scientific; Town of Middleton (WI); On-site; USD 110,000 - 160,000; Full time

Job summary

Thermo Fisher Scientific in Middleton, Wisconsin is seeking a Senior Study Lead to oversee multiple complex routine projects in release, stability, and quality control. You will ensure data quality, regulatory compliance, and client alignment while guiding study leadership and analysts.

You will mentor staff, drive audit readiness, develop study plans, review protocols and reports, and collaborate with QA and SMEs to deliver compliant results on time.

Qualifications

• Advanced knowledge of routine analytical testing, instrumentation, and laboratory systems.
• Strong understanding and application of regulatory requirements (e.g., GMP, FDA guidelines).
• Expertise in data evaluation, including trend analysis, outlier detection, and interpretation of complex data sets.
• Demonstrated leadership in managing multiple complex or large-scale routine projects.
• Highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint), with functional skills in Power BI.
• Skilled in the use of laboratory information management systems (LIMS).
• Excellent written and verbal communication skills, with the ability to draft high-quality technical documents.
• Strong technical writing skills, including authorship/review of protocols, reports, and quality records.
• Ability to conduct root cause analyses, lead investigations, and develop corrective/preventive actions.
• Demonstrated capability to train, mentor, and coach junior staff and Study Lead team members.
• Proven ability to identify and implement process improvements and drive continuous improvement.
• Strong attention to detail, data integrity, and documentation practices.
• Ability to build and maintain positive relationships with internal teams and clients.

Responsibilities

• Draft and/or approve detailed technical documents and perform data reviews.
• Design and manage robust study plans and program strategies.
• Identify solutions for technical challenges and mentor scientists.
• Identify and remove obstacles and optimize laboratory processes.
• Lead and oversee routine project execution.
• Collaborate with stakeholders to implement changes.
• Hold authority for routine investigations and risk assessments.
• Communicate complex information to clients and prepare for audits.
• Lead audit readiness and address audit observations (CAPAs).
• Review client deliverables for quality and compliance.
• Develop KPIs and drive continuous improvement.
• Support contract reviews and estimate resources.
• Train and mentor staff on compliance and audit readiness.
• Ensure study quality, data integrity, and GMP compliance.

Skills

Analytical testing

Regulatory knowledge

Data analysis

Project leadership

Documentation

Communication

Mentoring

GMP compliance

LIMS

Education

Bachelor's degree or equivalent

Relevant formal academic qualification

Tools

Power BI

Microsoft Excel

LIMS

Office suite

Job description

Thermo Fisher Scientific in Middleton, Wisconsin is seeking a Senior Study Lead to oversee multiple complex routine projects in release, stability, and quality control. You will ensure data quality, regulatory compliance, and client alignment while guiding study leadership and analysts.

You will mentor staff, drive audit readiness, develop study plans, review protocols and reports, and collaborate with QA and SMEs to deliver compliant results on time.