Senior Chemist- Raw Materials

SUMMARY

The Raw Materials Senior Chemist is responsible for performing and overseeing analytical testing of raw materials in a fast paced CRO environment. This role supports GMP/GLP aligned laboratory operations through accurate analysis, documentation, and review of chemical data using intermediate to advanced knowledge of analytical chemistry, instrumentation, and raw material specifications. The Senior Chemist provides technical guidance, contributes to process improvements, and demonstrates leadership potential within the analytical team.

ESSENTIAL FUNCTIONS

• Performs intermediate to advanced analytical testing of raw materials using techniques such as HPLC, GC, FTIR, UV Vis, titration, wet chemistry, and other instrumentation per SOPs, compendial methods, and client requirements.

• Reviews, interprets, and documents analytical data with a high level of accuracy; ensures compliance with internal quality standards and regulatory expectations.

• Conducts peer review of data, worksheets, and reports; supports junior staff by providing feedback and technical clarification.

• Oversees or assists with the completion, review, and processing of laboratory documentation, including raw data, COAs, logbooks, and electronic records.

• Provides analytical insight and recommendations to management and project teams regarding raw material testing, method execution, and laboratory best practices.

• Supports client communication by helping address technical questions, participating in investigations, and contributing to corrective and preventive actions (CAPAs) when needed.

• Evaluates laboratory operations, testing trends, and quality metrics to identify opportunities for improvement; presents findings and recommendations to leadership.

• Ensures accuracy and reliability of testing through routine equipment calibration, troubleshooting, and maintenance; collaborates with team members to resolve discrepancies.

• Participates in cross functional or chemistry focused projects, including method transfers, validations, and process improvements; contributes to planning, timelines, and resource needs.

• Maintains a clean, safe, and compliant laboratory environment; adheres to all safety policies, chemical hygiene requirements, and regulatory guidelines.

• Interprets and applies laboratory policies, SOPs, and relevant regulations (USP, EP, ISO, GMP/GLP) with minimal guidance.

• Contributes to a collaborative, efficient work environment by actively participating in team initiatives and supporting departmental goals.

• Demonstrates professional, courteous behavior when interacting with clients, colleagues, and leadership; supports a positive and productive workplace culture.

QUALIFICATIONS

Education & Experience

• Bachelor's degree in Chemistry, Biochemistry, or a closely related scientific field.

• Minimum offive (5) years of analytical chemistry experience in a CRO, pharmaceutical, or regulated laboratory environment, preferably with raw materials testing responsibilities.

• Experience providing technical guidance, mentoring, or informal leadership is strongly preferred.

• Equivalent combinations of education and experience may be considered.

REQUIRED KNOWLEDGE & SKILLS

Knowledge

• Intermediate to advanced principles and practices of analytical chemistry, particularly raw material characterization.

• Working knowledge of GMP/GLP requirements, compendial testing (USP/EP/JP), and laboratory quality systems.

• Understanding of laboratory instrumentation, calibration, troubleshooting, and maintenance.

• Familiarity with LIMS, chromatography data systems, and standard laboratory software.

• Knowledge of project coordination and cross functional collaboration in a CRO environment.

• Strong understanding of safe laboratory practices and chemical handling.

Skills

• Performing intermediate to advanced analytical testing with accuracy and efficiency.

• Reviewing, interpreting, and documenting complex analytical data.

• Providing technical guidance and supporting the development of junior staff.

• Managing multiple projects and deadlines in a client driven environment.

• Preparing clear, concise technical reports and documentation.

• Exercising sound judgment, initiative, and problem solving skills.

• Communicating effectively with colleagues, clients, and leadership.

• Building strong working relationships and contributing to team success.

• Delivering effective oral presentations to peers and management.

PHYSICAL & MENTAL REQUIREMENTS

• Ability to work in both laboratory and office environments; operate standard lab instrumentation; and sit or stand for extended periods.

• Ability to lift up to 40 pounds occasionally and up to 10 pounds frequently.

• Visual acuity for reading printed and electronic materials; ability to communicate clearly in person and by phone.

WORKING ENVIRONMENT

• Work performed in laboratory and office settings.

• Exposure to chemicals, solvents, fumes, and raw material samples typical of an analytical testing laboratory.

• Use of appropriate PPE required.