Study Lead - Cell Lab

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Relocation assistance is not provided, and candidates must be legally authorized to work in the United States without sponsorship. A comprehensive background check, including drug screening, is required.

About the Role

The Study Lead is responsible for managing multiple routine projects (release, stability, and quality control), interacting with clients and internal stakeholders to communicate updates, providing deliverables, reviewing and evaluating data, writing scientific reports and protocols, and managing quality records. This role ensures adherence to regulatory guidelines and scientific conduct of routine testing.

The Study Lead directs and oversees testing and troubleshooting on established methods using multiple analytical instruments and detection techniques, evaluates/trends and interprets data, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional lab or client-specific requirements. This role drives routine study execution and technical client communication for established methods but does not independently determine scientific conclusions for non-routine issues. Technical direction is consulted from senior staff for complex investigations.

Responsibilities

• Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables.
• Reinforce best practices through example and delivery of routine study activities.
• Communicate project plans, status updates, deliverables, and routine technical findings to internal stakeholders and clients, escalating risks or non-routine issues as appropriate.
• Manage multiple routine projects, interact with clients and internal stakeholders, provide deliverables, review and evaluate data, write reports and protocols, and oversee quality records.
• Provide guidance, resources, mentoring, and/or training to laboratory staff to foster independent routine test execution and troubleshooting.
• Prepare and/or review routine study protocols, project status reports, final study reports, and other project-related technical documents, including quality records.
• Collate, organize, and evaluate/trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs.
• Monitor daily project-related operations to ensure adherence to SOPs, company policies, and regulatory standards, reporting non-compliance issues to management.
• Assist in risk assessments, recommend risk mitigation strategies, and advise clients on study design.
• Support continuous improvement initiatives, identify technical obstacles, and implement process improvement strategies.
• Participate in project problem-solving sessions, escalate issues when necessary, and incorporate appropriate resources or subject matter experts to drive solutions.
• Execute/oversee studies within established methods, protocols, and decision frameworks, escalating non-routine or complex issues to senior technical staff.
• Ensure timely and accurate delivery of routine project outputs, maintaining data integrity and compliance with SOPs, regulatory requirements, and client expectations.
• Apply standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and SME guidance.
• Identify and communicate risks to project timelines, data quality, or deliverables, and escalate appropriately.
• Support audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participate in client audits or site visits and address audit findings under guidance from senior staff.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• 5+ years of relevant experience or an equivalent combination of education, training, and experience.
• Knowledge of routine analytical testing and applicable technology/instrumentation.
• Working knowledge of GMP requirements and data integrity principles.
• Ability to lift and move objects up to 40 pounds without assistance.
• Adherence to all Good Manufacturing Practices (GMP) safety standards.
• Ability to work in a laboratory setting with some degree of PPE (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Skills

• Excellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure, and productivity.
• Versed in data analysis to identify trends or outliers.
• Ability to manage multiple assignments with challenging/conflicting deadlines.
• Proficient in Microsoft suite applications (e.g., Word, Excel, Power BI, PowerPoint, Teams, SharePoint).
• Familiarity with data collection software leveraged for analytical testing.
• Strong attention to detail and problem-solving skills.
• Effective written and verbal communication skills, including technical writing.
• Demonstrated experience in identification and resolution of conflicts in a professional environment.
• Ability to maintain a high degree of confidentiality with client information and data.
• Demonstrated ability to attain, maintain, and apply a working knowledge of applicable procedural documents.
• Positive attitude, enthusiasm toward work, and ability to work well with others.
• Demonstrated ability to receive and apply constructive feedback.
• Ability to train, coach, and mentor junior staff.

Work Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments, including laboratory and office settings.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.