Staff Scientist – Biopharmaceuticals, GMP Full-time

Staff Scientist

This is a fully onsite role based at our GMP Laboratory in Middleton, Wisconsin. 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.

The Staff Scientist provides expert-level technical leadership within the laboratory as a senior scientific contributor and recognized technical authority. This role delivers oversight for nonroutine programs (analytical development, validation, transfer) and/or serves as a subject matter expert (SME) for specific analytical technologies, while maintaining an active laboratory presence. In this role, you would operate as a well-established non-routine technical lead for method establishment work and is grounded in laboratory execution, technical decision making, and scientific oversight rather than routine study management (release, stability or quality control).

The Staff Scientist provides technical leadership and mentorship to laboratory staff, guiding execution across multiple client programs. This role partners closely with laboratory leadership to ensure scientific rigor, regulatory compliance, and the long-term sustainability of technical capabilities and processes. This role serves as a technical driver and decision-maker for non-routine testing, method establishment, complex investigations within assigned scope, and may assist Study Leads on complex technical challenges. However this role does not own routine study timelines, client communications, or client deliverables.

Role Responsibilities:

• Provides technical oversight for complex, non-routine analytical testing (analytical development, validation, and transfer), method establishment, and technology-driven programs.
• Serves as a senior technical authority and SME for one or more analytical technologies, platforms, or scientific disciplines.
• Guides scientific decision-making to ensure appropriate experimental design, execution strategy, and data interpretation.
• Reviews and/or approves technical documents including methods, protocols, reports, and quality records to ensure quality and compliance.
• Designs, executes, and/or oversees complex laboratory experiments, development, transfer, and validation activities.
• Maintains sufficient hands-on laboratory engagement to ensure technical credibility and executional alignment.
• Supports resolution of complex technical issues, atypical results, and escalated investigations through direct scientific involvement.
• Contributes to quality management by conducting in-depth data analysis and root cause analysis to identify issues and support continuous improvement.
• May function as a well-established non-routine technical lead for multiple non-routine or method establishment programs, providing guidance and oversight to Senior Scientist and other technical leads.
• May alternatively serve as a technology SME, advancing scientific capabilities, optimizing methods, and defining best practices for assigned platforms.
• Guides and mentors Senior Scientist and staff, developing advanced technical skills, critical thinking, and scientific judgment.
• Supports identification and development of high-potential technical talent in collaboration with laboratory leadership.
• Reinforces a culture of scientific excellence, accountability, and continuous improvement.
• Collaborates with laboratory leadership, Quality, and Program Managers to align technical execution with program objectives and regulatory expectations.
• Participates in client interactions as a senior technical representative, supporting discussions related to methods, data interpretation, and technical strategy.
• Provides technical and regulatory recommendations to internal teams and clients as needed.

Key Requirements:

• 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).

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:

• Expert knowledge of analytical testing techniques, laboratory instrumentation, and method execution in a regulated environment, with the ability to provide technical oversight across multiple methods, programs, or technologies.
• Demonstrated ability to independently design, execute, and oversee complex testing, investigations, and non-routine laboratory activities, including method establishment and advanced problem resolution.
• Advanced troubleshooting, problem-solving, and critical-thinking skills, with a proven ability to identify systemic root causes and implement sustainable technical solutions.
• Proven ability to develop, maintain, and apply deep subject matter expertise in one or more analytical methods, assays, platforms, or technologies, and to leverage that expertise across programs.
• Strong data analysis capabilities, including trend evaluation, outlier detection, and interpretation of complex or atypical data sets to inform scientific and quality decisions.
• Demonstrated commitment to data integrity, quality, and scientific rigor, with advanced understanding of GMP requirements and regulatory expectations.
• Ability to guide scientific and technical decision-making to ensure appropriate experimental design, execution strategy, and compliance.
• Excellent organizational and prioritization skills, with the ability to balance multiple complex technical responsibilities and shifting priorities while maintaining focus and productivity.
• Demonstrated ability to mentor, coach, and technically develop Senior Scientist and junior staff, strengthening scientific judgment, troubleshooting capability, and technical depth through hands-on guidance.
• Strong written and verbal communication skills, including authorship and review of complex technical documents and the ability to clearly communicate scientific concepts to internal and external stakeholders.
• Proven ability to collaborate effectively across laboratory, quality, and project teams, influencing outcomes through technical expertise rather than formal authority.
• Demonstrated experience identifying and constructively resolving technical or professional conflicts in a collaborative environment.
• Ability to maintain a high degree of confidentiality with client information, data, and proprietary methodologies.
• Proficiency with Microsoft Office applications (e.g., Word, Excel, PowerBI, PowerPoint, Teams, SharePoint) and familiarity with laboratory data systems and software supporting analytical testing.
• Demonstrated openness to feedback and continuous improvement, with the ability to apply lessons learned to enhance technical performance and laboratory capability.

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• 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.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• 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.