Senior Staff Scientist, Extractables & Leachables (GMP)

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials, Working at heights Job Description Senior Staff Scientist Department: Extractables & Leachables Location: Middleton, Wisconsin 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 Role The Senior Staff Scientist is a senior technical leader and department driver responsible for advancing laboratory capabilities, scientific excellence, and operational effectiveness across technical laboratory testing. This role demonstrates advanced mass spectrometry technical expertise, deep extractables & leachables regulatory knowledge, laboratory leadership, and complex study leadership. The Senior Staff Scientist evaluates, implements, and scales new technologies, including but not limited to high-resolution mass spectrometry; improves laboratory systems, processes, and procedures; and provides expert guidance on scientific, technical, and regulatory matters. They mentor and develop scientific staff, support management through technical leadership, and resolve complex scientific challenges with clients and internal teams. The Senior Staff Scientist leads complex analytical client studies and extractable/leachable programs, overseeing integrated planning, execution, data evaluation, resource coordination, and client communication. The role is defined by department-level impact, broad technical influence, and ownership of scientific direction and standards across the department. This role approves department level scientific direction, standards, and complex technical decisions. This role is responsible for the scientific scope, accuracy and regulatory alignment for method feasibility, development, and validation. Provides technical and regulatory consulting and oversight for internal groups and clients regarding method establishment programs. Oversees troubleshooting on multiple analytical instruments and multiple detection techniques, data calculation and interpretation, and records data in adherence with Thermo Fisher Scientific, Inc. SOPs and any additional requirements specific to the lab and / or client. Provides mentorship and technical guidance to scientific staff, acting as program lead to provide updates and reports for multiple clients, and collaborating with lab leaders to ensure client needs are met. The position also focuses on implementing strategies for project profitability and long-term quality improvements. Key Responsibilities : Acts as extractable/leachable technical leader, driving scientific direction, innovation, and continuous improvement across technical laboratory testing. Guides technical direction for proposals and supports client discussions around scope of work. Serves as a senior technical representative with clients, providing guidance on scientific issues, study strategy, and technical requirements. Evaluates scientific trends, implements, and champions new technologies, methodologies, and capabilities to improve productivity, quality, and long-term business outcomes. Leads improvements to laboratory systems, processes, and procedures to strengthen efficiency, robustness, and regulatory compliance. Partners in cross-site technical discussions and decision-making to promote alignment and standardization. Serves as a trusted technical advisor to laboratory leadership and senior management on scientific, operational, and regulatory topics. Serves as a senior technical authority and is recognized as an extractable/leachable subject matter expert across LCMS and GCMS technologies while integrating departmental priorities and contributing to cross-site technical decisions and alignment. Provides expert input on experimental design, technical strategy that coordinates across all required methods, data interpretation, and extractable/leachable regulatory considerations. Resolves complex scientific and technical issues involving clients, laboratory staff, and cross-functional partners. Reviews and approves complex technical deliverables, including methods, protocols, reports, investigations, and SOPs. Guides and supports program teams conducting complex technical laboratory studies and programs. Provides integrated technical leadership for study planning, execution strategy, resource coordination, data evaluation, and client communication to efficiently delivering projects on-time and meeting regulatory standards. Maintains sufficient laboratory engagement to ensure technical credibility, executional alignment, and scientific rigor. Oversees escalated technical issues, quality records, and high-impact scientific decisions. Provides mentorship, coaching, and oversight to scientific staff across all levels to build technical expertise, strengthen scientific judgement, and support career development. Contributes to succession planning and development of future technical leaders. Provides technical leadership in complex client interactions and audits. Key Qualifications: Education and Experience: 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 12+ years experience) or equivalent combination of education, training, & experience. PhD or equivalent experience in Chemistry, Biochemistry, or related field strongly preferred. 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 relevant to extractables and leachables, LCMS, GCMS, and related instrumentation, and method execution in a regulated environment, with the ability to provide technical oversight and strategic direction across multiple methods, programs, technologies, or service offerings. Extensive experience developing and validating methods for extractables and leachables or similar strongly preferred. Strong written and verbal communication skills, including authorship and critical review of complex technical documents, and the ability to clearly communicate scientific concepts, risks, and recommendations to senior internal and external stakeholders. Excellent o