Analytical Chemist

Job Description

This role offers the opportunity to contribute to a growing pharmaceutical organization by performing analytical testing and supporting laboratory operations in a GMP-regulated environment. The Analytical Chemist will play a key role in method development and validation, data analysis, and cross-functional collaboration to support both product development and commercial activities.

This role offers the opportunity to contribute to a growing pharmaceutical organization by performing analytical testing and supporting laboratory operations in a GMP-regulated environment. The Analytical Chemist will play a key role in method development and validation, data analysis, and cross-functional collaboration to support both product development and commercial activities.

• Perform analytical testing using HPLC and other laboratory instrumentation in a GMP-regulated environment.
• Execute analytical method validation, method transfer, and troubleshooting activities to ensure robust and reliable methods.
• Analyze and interpret laboratory data, ensuring accuracy, integrity, and compliance with GMP requirements and internal procedures.
• Author and review technical documentation, including analytical protocols, test methods, validation reports, and data summaries.
• Collaborate closely with Quality, Manufacturing, and other cross-functional teams to support product development and commercial manufacturing activities.
• Maintain accurate, complete, and compliant laboratory records in accordance with GMP documentation standards and laboratory practices.
• Ensure adherence to regulatory guidelines, internal quality systems, and laboratory safety procedures during all testing activities.
• Support continuous improvement initiatives within the laboratory by identifying opportunities to optimize methods, workflows, and documentation.

• Bachelor's degree in Chemistry or a closely related scientific discipline.
• 2–5+ years of experience in an analytical chemistry role, preferably within a GMP-regulated laboratory.
• Hands-on experience operating and maintaining HPLC systems for routine and specialized testing.
• Experience performing analytical method validation and/or method transfer activities.
• Pharmaceutical industry experience, with familiarity in supporting product development or commercial manufacturing.
• Knowledge of GMP documentation requirements and good laboratory practices, including data integrity principles and proper record-keeping.
• Ability to accurately analyze and interpret analytical data and clearly communicate results in written reports.
• Strong attention to detail and commitment to maintaining high-quality and compliant laboratory work.

• Experience troubleshooting HPLC methods and instrumentation issues to minimize downtime and improve data quality.
• Demonstrated ability to author and review technical documentation such as protocols, test methods, and validation reports.
• Comfort working in cross-functional teams, collaborating with Quality, Manufacturing, and other technical groups.
• Strong organizational skills with the ability to manage multiple analytical tasks and priorities in a dynamic environment.
• Effective written and verbal communication skills for documenting work and interacting with colleagues across departments.

The position is based in a GMP-regulated pharmaceutical laboratory environment that emphasizes quality, safety, and compliance. You will work with HPLC systems and other analytical instruments, following established laboratory procedures and documentation standards. The role involves close collaboration with Quality and Manufacturing teams and offers exposure to both product development and commercial operations. The environment is fast-paced and detail-oriented, with a focus on accurate data generation, thorough record-keeping, and adherence to regulatory and internal quality guidelines.

Standard laboratory attire, including appropriate personal protective equipment, is required while performing laboratory activities.

This is a Permanent position based out of Irvine, CA.