Senior Study Lead - GMP Lab, Biopharmaceuticals

Job description

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 LeadDepartment: BiopharmaceuticalsLocation: Middleton, Wisconsin This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Role OverviewThe 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. What you will do: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, develop innovative and effective solutions, and mentor scientists in advanced problem-solving methods to enhance overall project outcomes. Identify and eliminate obstacles, develop strategic improvement plans, and continuously identify opportunities to optimize laboratory processes and project efficiency. Lead and oversee the execution and coordination of routine projects using established methods. Identify improvement opportunities and collaborate with internal stakeholders to evaluate and implement changes. Hold decision-making authority for routine investigations, deviations, and risk-based assessments, ensuring scientifically sound, compliant, and well-documented outcomes. Communicate complex technical information concisely and effectively with clients, lead technical visits and discussions, and prepare for audits or site visits to ensure compliance and client satisfaction. Lead audit readiness efforts by ensuring studies, documentation, and processes are inspection-ready; serve as a key contact during audits and drive resolution of audit observations, including CAPAs and systemic improvements. Review and/or approve client deliverable documents including routine protocols, reports, and quality records to ensure quality and compliance. Develop and evaluate technical Key Performance Indicators (KPIs), collaborate closely with clients and internal stakeholders to drive continuous improvement, and ensure alignment with project goals and regulatory standards. Support comprehensive contract reviews, evaluate scientific proposals with a critical eye, provide well-informed recommendations, and accurately estimate resource needs to support project planning and execution. Train and mentor Study Lead and other staff on compliance, audit readiness, and unbiased problem-solving techniques, promote ethical behavior and integrity, and actively support continuous improvement initiatives to foster a culture of excellence. Accountable for overall study quality, data integrity, and compliance across assigned programs, ensuring alignment with GMP, regulatory requirements, and internal standards. Key RequirementsEducation and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years experience) or equivalent combination of education, training, and experience. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities: Advanced knowledge of routine analytical testing, instrumentation, and laboratory systems, with the ability to troubleshoot established methods. Strong understanding and application of regulatory requirements (e.g., GMP, FDA guidelines), with the ability to advise on compliance and risk mitigation strategies. Expertise in data evaluation, including trend analysis, outlier detection, and interpretation of complex data sets to support scientific and operational decisions. Demonstrated leadership in managing multiple complex or large-scale routine projects, balancing priorities, resolving conflicts, and meeting challenging deadlines. Highly proficient in Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint), with functional skills in Power BI for data visualization and reporting. Skilled in the use of laboratory information management s