Study Lead - Biopharm

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; any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening.

About the role

As the Study Lead, you will manage multiple routine projects (release, stability, and quality control), interact with clients and internal stakeholders to communicate updates, provide deliverables, review and evaluate data, write scientific reports and protocols, and manage quality records. This role ensures adherence to regulatory guidelines and scientific conduct of routine testing. You will direct and oversee testing and troubleshooting on established methods using multiple analytical instruments and detection techniques, evaluate/trend and interpret data, and record data in adherence with Thermo Fisher Scientific SOPs and any additional lab or client-specific requirements.

This role drives routine study execution and technical client communication for established methods and defined scopes but does not independently determine scientific conclusions for non-routine (development, validation, transfer, etc.) or method lifecycle-impacting issues. When investigation outcomes exceed routine complexity, technical direction is consulted from the Senior Study Lead or Staff Scientist+ in accordance with the Decision Making Framework and Standard Work.

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, concerns, or non-routine issues as appropriate.
• Manage multiple routine projects, interact with clients and internal stakeholders to communicate updates, provide deliverables, review and evaluate data, write reports and protocols, and oversee quality records.
• Provide guidance, resources, mentoring, and/or training to laboratory staff, fostering 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 inclusive of 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 SMEs to drive effective solutioning.
• Execute/oversee studies within established methods, protocols, and decision frameworks, escalating non-routine, complex, or ambiguous issues to senior technical staff.
• Apply standard troubleshooting approaches to resolve routine technical issues, leveraging existing knowledge, historical data, and subject matter expert (SME) guidance as needed.
• 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.
• Previous experience comparable to 5+ years or equivalent combination of education, training, and directly related experience.
• Knowledge of routine analytical testing and applicable technology/instrumentation.
• 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.
• Ability to attain, maintain, and apply a working knowledge of applicable procedural documents.
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
• Demonstrated ability to receive and apply constructive feedback.
• Ability to train, coach, and mentor junior staff.
• Working knowledge of GMP requirements and data integrity principles.

Environmental Conditions

• Able to lift and move objects up to 40 pounds without assistance.
• Adherence to all Good Manufacturing Practices (GMP) safety standards.
• Laboratory setting with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Will work with hazardous/toxic materials.
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.