Study Lead - BioPharmaceuticals (GMP Lab)

Thermo Fisher Scientific•Middleton, WI

4d•Onsite

About The Position

The Study Lead in Thermo Fisher Scientific’s Biopharmaceuticals department manages multiple routine GMP laboratory projects, including release, stability, and quality-control studies. The role coordinates study plans, timelines, and deliverables; communicates project updates and routine technical findings to clients and internal stakeholders; reviews and evaluates data; prepares scientific reports and protocols; and manages quality records. The Study Lead directs and oversees testing and troubleshooting using established methods, analytical instruments, and detection techniques, while ensuring accurate data, data integrity, and adherence to SOPs, regulatory requirements, and client-specific requirements. This role leads routine study execution and technical client communication within defined scopes and decision frameworks. It does not independently determine scientific conclusions for non-routine work or method lifecycle-impacting issues. Complex, ambiguous, or non-routine matters are escalated to senior technical staff, such as a Senior Study Lead or Staff Scientist. The Study Lead also supports staff training and mentoring, risk assessments, continuous improvement, problem-solving, and audit readiness. This is a fully onsite position at the GMP laboratory in Middleton, Wisconsin. Applicants may be located anywhere in the United States, but relocation assistance is not provided. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check that includes drug screening.

Requirements

Bachelor’s degree or equivalent and a relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5 or more years; an appropriate combination of education, training, and/or directly related experience may be considered equivalent.
Knowledge of routine analytical testing and applicable technology and instrumentation.
Excellent organizational skills and ability to adapt to changing priorities while maintaining focus, composure, and productivity.
Ability to analyze data to identify trends or outliers.
Ability to manage multiple assignments with challenging or conflicting deadlines.
Proficiency with Microsoft applications, including 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.
Ability to lift and move objects up to 25 pounds.
Ability to work in non-traditional work environments and use and learn standard office equipment and technology proficiently.
Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Responsibilities

Collaborate with internal stakeholders to translate project requirements into study design plans and manage project timelines and deliverables.
Manage multiple routine release, stability, and quality-control projects, coordinating with clients and internal stakeholders on updates and deliverables.
Communicate project plans, status updates, deliverables, and routine technical findings; escalate risks, concerns, and non-routine issues as appropriate.
Reinforce best practices through example and delivery of routine study activities.
Provide guidance, resources, mentoring, and training to laboratory staff to support independent routine test execution and troubleshooting.
Prepare and/or review routine study protocols, project status reports, final study reports, and other technical documents, including quality records.
Collate, organize, evaluate, and trend data to ensure accuracy, integrity, and compliance with protocols, methods, and SOPs.
Monitor daily project-related operations for adherence to SOPs, company policies, and regulatory standards, and report non-compliance 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, escalate issues when necessary, and involve appropriate resources or subject matter experts.
Execute and oversee studies using established methods, protocols, and decision frameworks; escalate non-routine, complex, or ambiguous issues to senior technical staff.
Ensure timely and accurate delivery of routine project outputs in accordance with data-integrity, SOP, regulatory, and client requirements.
Apply standard troubleshooting approaches to resolve routine technical issues, using existing knowledge, historical data, and subject matter expert guidance as needed.
Identify and communicate risks to project timelines, data quality, or deliverables, and escalate appropriately.
Maintain study documentation, data, and records in an inspection-ready state; participate in client audits or site visits and address audit findings under senior-staff guidance.