Senior Scientist - GMP Laboratory

Senior Scientist

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. 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 Senior Scientist independently performs complex laboratory testing and provides hands-on technical coaching and mentorship within the laboratory. This role is focused on being an in-lab proven contributor who actively executes, troubleshoots, and improves testing activities while developing in-depth subject matter expertise in assigned methods, assays, or analytical platforms.

A Senior Scientist may operate either as a non-routine technical contributor for method development, transfer, or validation activities or as a key technical resources for complex or priority routine testing. In all cases, the Senior Scientist remains directly involved in laboratory execution and testing oversight, owns non-routine technical deliverables within defined scope, and mentors Scientist I and II staff to ensure high-quality, consistent laboratory performance.

This role serves as a senior technical contributor and escalation resource within the laboratory. The Senior Scientist is responsible for the quality and technical accuracy of assigned deliverables (data, reports, methods, and protocols) but does not own overall program delivery, routine study management, or primary technical client communication. Client interaction may occur for method-specific technical discussions but does not include ownership of broader client relationships or project coordination.

Scientific decisions that impact method lifecycle, validation strategy, or broader testing models are escalated to Staff Scientist + for approval. This role is distinct from a Study Lead and does not own routine study/program management, project coordination, or primary client-facing responsibilities.

• 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 5+ years' experience) or equivalent combination of education, training, & experience.

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.

• Previous GMP Laboratory experience strongly preferred
• Previous experience with HPLC, CE, iCE, or ELISA strongly preferred
• Previous experience with cell culture, mammalian cell culture, flow cytometry, PCR, ELISA, or cell-based bioassays strongly preferred
• Previous experience with method troubleshooting, optimization, and/or validation preferred
• Advanced knowledge of analytical testing techniques, laboratory instrumentation, and method execution in a regulated environment.
• Demonstrated ability to independently execute complex testing, investigations, and non-routine laboratory activities.
• Strong troubleshooting, problem-solving, and critical thinking skills, with the ability to identify analytical challenges at the source and implement effective solutions.
• Proven ability to develop and maintain subject matter expertise in assigned methods, assays, or analytical platforms.
• Versed in data analysis with the ability to identify trends, outliers, and atypical results.
• Strong attention to detail and commitment to data integrity, quality, and accuracy.
• Working knowledge of GMP requirements and data integrity principles.
• Excellent organizational skills with the ability to adapt to changing priorities while maintaining focus, composure, and productivity.
• Ability to prioritize and execute multiple assignments with challenging or conflicting deadlines in a dynamic laboratory environment.
• Ability to mentor and technically develop scientific staff through hands-on guidance and knowledge transfer.
• Strong…