Senior Study Lead, Cell and Gene Therapy

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Senior Study Lead Department: Cell and Gene Therapy Location: Middleton, Wisconsin At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Overview The Senior Study Lead is responsible for overseeing and managing multiple complex or large-scale routine projects (release, stability or quality control), ensuring seamless interaction with clients and internal leadership to communicate project updates, milestones, and strategic priorities. This role delivers high-quality outputs, conducts thorough reviews and evaluations of data, and prepares comprehensive protocols and reports. The Senior Study Lead is accountable for managing quality records and ensuring strict adherence to regulatory guidelines and scientific standards for routine testing, including release, stability, and quality control projects. The Senior Study Lead holds decision-making authority for routine investigations, deviations, and risk-based assessments, ensuring scientifically sound and compliant outcomes. Leveraging extensive knowledge of laboratory systems, regulatory guidelines, and quality requirements, the Senior Study Lead provides expert oversight of routine testing, supports data trend evaluation, and proactively identifies risks or improvement opportunities. This role actively collaborates with cross-functional teams, including internal stakeholders, quality assurance, and SMEs, to align on project goals and drive successful outcomes. The Senior Study Lead also mentors Study Lead team members and analysts, fosters audit readiness, and contributes to a culture of continuous improvement, scientific excellence, and ethical conduct. This role is accountable for driving routine study delivery, documentation, and client alignment, but may consult with Staff Scientist + for scientific conclusions on method-related decisions as well as overall study quality, client satisfaction, and successful delivery of complex or high-impact programs beyond individual project execution, and serves as a primary escalation point for complex technical and client-related issues associated with routine testing.

Independently draft and/or approve detailed and comprehensive technical documents, perform meticulous data/report reviews, and provide constructive feedback and guidance to Study Lead to ensure high-quality deliverables. Design and manage robust project study plans and complex program strategies, ensuring technical accuracy, high-quality outcomes, and alignment with client expectations and business objectives. Proactively identify solutions for technical challenges associated with routine testing,