Senior Staff Scientist, Extractables & Leachables (GMP)

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. Relocation assistance is not provided for this position. 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.

About 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.

Responsibilities

• Act as extractable/leachable technical leader, driving scientific direction, innovation, and continuous improvement across technical laboratory testing.
• Guide technical direction for proposals and support client discussions around scope of work.
• Serve as a senior technical representative with clients, providing guidance on scientific issues, study strategy, and technical requirements.
• Evaluate scientific trends, implement, and champion new technologies, methodologies, and capabilities to improve productivity, quality, and long-term business outcomes.
• Lead improvements to laboratory systems, processes, and procedures to strengthen efficiency, robustness, and regulatory compliance.
• Partner in cross-site technical discussions and decision-making to promote alignment and standardization.
• Serve as a trusted technical advisor to laboratory leadership and senior management on scientific, operational, and regulatory topics.
• Serve as a senior technical authority and be 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.
• Provide expert input on experimental design, technical strategy that coordinates across all required methods, data interpretation, and extractable/leachable regulatory considerations.
• Resolve complex scientific and technical issues involving clients, laboratory staff, and cross-functional partners.
• Review and approve complex technical deliverables, including methods, protocols, reports, investigations, and SOPs.
• Guide and support program teams conducting complex technical laboratory studies and programs.
• Provide integrated technical leadership for study planning, execution strategy, resource coordination, data evaluation, and client communication to efficiently deliver projects on-time and meeting regulatory standards.
• Maintain sufficient laboratory engagement to ensure technical credibility, executional alignment, and scientific rigor.
• Oversee escalated technical issues, quality records, and high-impact scientific decisions.
• Provide mentorship, coaching, and oversight to scientific staff across all levels to build technical expertise, strengthen scientific judgement, and support career development.
• Contribute to succession planning and development of future technical leaders.
• Provide technical leadership in complex client interactions and audits.

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 12+ years) or equivalent combination of education, training, & experience.
• PhD or equivalent experience in Chemistry, Biochemistry, or related field strongly preferred.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including a drug screening.
• Able to lift and move objects up to 40 pounds without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Ability to work in cold room/freezers (-22°F/-6°C), laboratory setting, office, and environments with loud noises (equipment/machinery).
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Ability to stand for full shift.
• Exposure to strong odors (chemical, lubricants, biological products, etc.).
• Will work with hazardous/toxic materials.
• Ability to work at heights.

Skills

• 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.

Environmental Conditions

• 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.