Study Lead - BioPharmaceuticals (GMP Lab)

Thermo Fisher Scientific•Middleton, WI

6d•Onsite

About The Position

The Study Lead manages multiple routine biopharmaceutical projects, including release, stability, and quality-control studies, at Thermo Fisher Scientific’s GMP laboratory in Middleton, Wisconsin. This is a fully onsite position. The role coordinates with clients and internal stakeholders, communicates study plans and progress, manages deliverables and quality records, reviews and evaluates data, and prepares scientific reports and protocols. It ensures routine testing is conducted in accordance with applicable regulatory guidelines, scientific practices, standard operating procedures (SOPs), and client-specific requirements. The Study Lead directs and oversees testing and routine troubleshooting using established methods, analytical instruments, and detection techniques. The role evaluates, trends, and interprets data; supports laboratory staff through guidance and training; monitors project operations and audit readiness; and contributes to risk mitigation and continuous improvement. The position works within defined methods and decision frameworks and escalates complex, ambiguous, non-routine, or method lifecycle-impacting issues to senior technical staff. The Study Lead is accountable for timely, accurate routine study outputs, data integrity, regulatory and SOP compliance, and communication of risks to stakeholders. Applicants must be legally authorized to work in the United States without sponsorship and pass a comprehensive background check, including drug screening. Relocation assistance is not provided.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
Experience providing knowledge, skills, and abilities comparable to 5 or more years of relevant experience; an appropriate combination of education, training, and directly related experience may be considered equivalent.
Knowledge of routine analytical testing and applicable technology and instrumentation.
Organizational skills and ability to adapt to changing priorities while maintaining focus, composure, and productivity.
Experience analyzing data to identify trends or outliers.
Ability to manage multiple assignments with challenging or conflicting deadlines.
Proficiency with Microsoft applications, such as Word, Excel, Power BI, PowerPoint, Teams, and SharePoint.
Familiarity with data-collection software used for analytical testing.
Strong attention to detail and problem-solving skills.
Effective written and verbal communication skills, including technical writing.
Demonstrated experience identifying and resolving conflicts in a professional environment.
Ability to maintain confidentiality of client information and data.
Ability to attain, maintain, and apply working knowledge of applicable procedural documents.
Positive attitude, enthusiasm toward work, and ability to work well with others.
Ability to receive and apply constructive feedback.
Ability to train, coach, and mentor junior staff.
Working knowledge of GMP requirements and data-integrity principles.
Legal authorization to work in the United States without sponsorship.
Ability to pass a comprehensive background check, including drug screening.
Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Ability to work upright and stationary and/or standing for typical working hours, lift and move objects up to 25 pounds, work in non-traditional work environments, use and learn standard office equipment and technology, and perform successfully under pressure while handling multiple projects or activities.

Responsibilities

Translate project requirements into study design plans with internal stakeholders, and manage project timelines and deliverables.
Manage multiple routine release, stability, and quality-control projects, including client and internal stakeholder communications, data review, deliverables, and quality records.
Reinforce best practices through example and execution of routine study activities.
Communicate project plans, status updates, deliverables, and routine technical findings to clients and internal stakeholders; escalate risks, concerns, and non-routine issues as appropriate.
Provide guidance, resources, mentoring, and training to laboratory staff to support independent routine testing and troubleshooting.
Prepare and/or review routine study protocols, project status reports, final study reports, and other project-related technical documents and quality records.
Organize, evaluate, and trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs.
Monitor daily project operations for compliance with SOPs, company policies, and regulatory standards, and report non-compliance issues to management.
Assist with 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, escalate issues when necessary, and engage appropriate resources or subject-matter experts.
Execute and oversee studies within established methods, protocols, and decision frameworks; escalate non-routine, complex, or ambiguous issues to senior technical staff.
Deliver routine project outputs accurately and on time while ensuring data integrity and compliance with SOPs, regulations, and client expectations.
Apply standard troubleshooting approaches to routine technical issues using existing knowledge, historical data, and subject-matter expert guidance as needed.
Identify and communicate risks to timelines, data quality, and deliverables, and escalate them appropriately.
Maintain audit readiness by ensuring study documentation, data, and records are complete, accurate, and inspection-ready; participate in client audits or site visits and address findings under senior staff guidance.