Summary/Objective:

The Senior Chemist serves as a technical leader within the laboratory, providing day-to-day guidance to chemists and laboratory staff while acting as the primary resource for analytical method development, method validation, and instrument troubleshooting. This role supports accurate, compliant, and timely laboratory operations through strong scientific judgment, documentation discipline, and hands-on technical expertise.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead and mentor laboratory personnel by providing technical direction, training, and support for routine and non-routine analytical work.
• Serve as the primary technical resource for method development, method optimization, method transfer, and method validation activities.
• Design, execute, document, and review analytical method validation and verification studies in accordance with applicable procedures, regulatory expectations, and industry best practices.
• Rely on USP and AOAC compendia, as applicable, to guide analytical method development, method verification, and method validation projects.
• Troubleshoot analytical methods, laboratory processes, and complex instrumentation issues.
• Review analytical data, laboratory notebooks, worksheets, and supporting documentation for accuracy, completeness, scientific soundness, and compliance with good documentation practices.
• Participate in and provide technical input for Out-of-Specification (OOS), deviation, and laboratory investigation activities, including root cause analysis and corrective/preventive actions.
• Support implementation, configuration, testing, and continuous improvement of the Laboratory Information Management System (LIMS), including workflow input and user feedback.
• Develop, revise, and maintain standard operating procedures, test methods, protocols, reports, and technical documentation.
• Promote a culture of safety, quality, scientific integrity, compliance, and continuous improvement within the laboratory.

Non Essential Functions

Support cross-functional activities as needed, including interactions with internal teams and laboratory workflow improvement initiatives.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

Work Environment

This position operates primarily in a regulated laboratory environment and requires adherence to applicable safety, quality, documentation, and compliance procedures. The role involves working with laboratory personnel, analytical instrumentation, laboratory information systems, technical documentation, and routine and non-routine analytical workflows.

Essential Functions Communication (Speech & Composition)

Expression of a level to communicate fluently with employees, customers and others in English to obtain and provide complex information. Vocalize and explain detailed data and problem-solve, both in-person and by telephone. Capable of interpretation of technical materials.

Comprehension and expression of a level to routinely draft narrative information, compose routine correspondence on own initiative, make comprehensive notes in English.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Employee will occasionally lift up to 40 pounds, walk, repeatedly bend, and smell. Employee will frequently read with attention to detail, seeing things near and far, distinguish basic colors and shades of colors and use routine hearing abilities. Employee will continuously sit for extended period of time, have routine hearing abilities.

Environmental Factors:

The environmental factors described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Employee will work independently but will frequently work closely with others. Employee will continuously work in an inside environment.

Travel

Moderate travel required - ability to travel occasionally for activities such as out-of-town training

Required Education, Skills and Experience

• Bachelor’s degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
• Five+ years of hands-on experience in a regulated laboratory environment, preferably in quality control, analytical development, pharmaceutical, chemical, environmental, or manufacturing support laboratories.
• Demonstrated experience with analytical method development, method validation, method verification, and method transfer.
• Strong working knowledge of laboratory instrumentation and troubleshooting, such as HPLC, LC/MS, GC/MS, ICP, UV-Vis, ELISA, titration, wet chemistry, and other relevant analytical platforms.
• Experience reviewing laboratory notebooks, analytical data, protocols, reports, and investigation documentation.
• Familiarity with OOS investigations, root cause analysis, CAPA development, and good documentation practices.
• Ability to interpret scientific data, identify technical issues, and communicate findings clearly to technical and non-technical stakeholders.

Preferred Education, Skills and Experience

• Previous experience leading, mentoring, training, or coordinating the work of chemists and laboratory technicians.
• Experience supporting LIMS implementation, validation, configuration, master data review, user acceptance testing, and laboratory workflow mapping.
• Knowledge of applicable regulatory, quality, and compendial standards, including USP and AOAC compendia, GMP, GLP, ISO, FDA, ICH, EPA, or other industry-specific requirements.
• Experience writing or reviewing method validation protocols, technical reports, SOPs, and investigation summaries.
• Experience interacting with auditors, clients, vendors, or cross-functional project teams.