Senior Staff Scientist, Extractables & Leachables (GMP)

JOB DESCRIPTION

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 organizational and prioritization skills, with the ability to balance multiple complex technical and strategic responsibilities while maintaining focus, productivity, and accountability at the department level.

• Demonstrated ability to independently design, execute, and oversee highly complex technical laboratory testing, investigations, and advanced scientific problem resolution, with accountability for outcomes beyond individual studies.

• Advanced troubleshooting, problem-solving, and critical-thinking skills, with a proven ability to identify systemic or cross-program root causes and implement sustainable technical solutions that improve department-level performance.

• Proven ability to develop, maintain, and apply deep subject matter expertise in multiple analytical methods, assays, platforms, or technologies, and to leverage that expertise to influence scientific direction and best practices across the department.

• Strong data analysis and interpretation capabilities, including evaluation of trends, outliers, and complex or atypical data sets to inform scientific, quality, and strategic decisions.

• Demonstrated commitment to data integrity, quality, and scientific rigor, with advanced understanding of GMP/GLP requirements and regulatory expectations, including application in complex or ambiguous situations.

• Ability to guide scientific and technical decision-making across programs to ensure appropriate experimental design, execution strategy, compliance, and long-term sustainability of laboratory practices.

• Demonstrated ability to mentor, coach, and technically develop Staff Scientist, Senior Scientist, and other technical staff, strengthening scientific judgment, troubleshooting capability, and technical depth through guidance and oversight.

• Proven ability to collaborate effectively across laboratory, quality, project, and leadership teams, influencing outcomes through technical credibility and expertise rather than formal authority.

• Demonstrated experience identifying, navigating, and constructively resolving complex technical or professional conflicts in a collaborative, solutions-oriented manner.

• Ability to maintain a high degree of confidentiality with client information, data, and proprietary methodologies while operating as a trusted technical advisor.

• Proficiency with Microsoft Office applications (e.g., Word, Excel, PowerBI, PowerPoint, Teams, SharePoint) and familiarity with laboratory data systems and software supporting analytical testing and performance monitoring.

• Demonstrated openness to feedback and continuous improvement, with the ability to apply lessons learned to enhance personal effectiveness, laboratory capability, and department-wide technical maturity.

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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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