Staff Scientist - Method Lead (Small Molecule)

Discover Impactful Work

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 non-routine programs (analytical development, validation, transfer) and/or serves as a subject matter expert (SME) for specific analytical technologies, while maintaining an active laboratory presence. The role operates as a well-established non-routine technical lead for method establishment work, grounded in laboratory execution, technical decision making, and scientific oversight rather than routine study management.

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 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 with comparable 8+ years of experience; OR PhD with 4+ years of experience; OR MS degree with 7+ years of experience.
• Equivalency of appropriate education, training and/or directly related experience may be considered sufficient.

Knowledge, Skills, Abilities

• Expert knowledge of analytical testing techniques, laboratory instrumentation, and method execution in a regulated environment.
• 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 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.
• Strong data analysis capabilities, including trend evaluation, outlier detection, and interpretation of complex or atypical data sets.
• 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 ability to balance multiple complex technical responsibilities.
• Demonstrated ability to mentor, coach, and technically develop Senior Scientist and junior staff.
• Strong written and verbal communication skills, including authorship and review of complex technical documents.
• Proven ability to collaborate effectively across laboratory, quality, and project teams.
• Demonstrated experience identifying and constructively resolving technical or professional conflicts.
• Ability to maintain a high degree of confidentiality with client information, data, and proprietary methodologies.
• Proficiency with Microsoft Office applications (Word, Excel, PowerBI, PowerPoint, Teams, SharePoint) and familiarity with laboratory data systems and software.