Senior Analytical Chemist

This role focuses on performing routine and advanced analytical testing of small-molecule pharmaceutical drug substances, finished dosage forms, and raw materials in a regulated laboratory environment. The chemist designs and executes method transfer and validation activities, supports analytical method development for purity, potency, and stability assessments, and contributes to cleaning validation efforts. The position requires strong hands-on experience with HPLC and GC, excellent documentation practices, and the ability to lead investigations and provide guidance to other laboratory personnel.

• Perform routine analysis of finished pharmaceutical dosage forms and raw materials using approved analytical methods and specifications.
• Design and execute method transfer protocols, including drafting and implementing method transfer documentation and authoring method transfer reports.
• Plan, perform, and document analytical method validations, including drafting validation protocols and writing comprehensive validation reports.
• Design and execute cleaning validation protocols and prepare final cleaning validation reports in compliance with applicable standards.
• Support the development of analytical methods to assess the purity, potency, and stability of drug substances and finished products.
• Operate HPLC, GC, and other laboratory analytical instruments, ensuring proper setup, calibration, and maintenance.
• Prepare reagents, standards, and sample solutions for testing, following established laboratory procedures.
• Assist in troubleshooting laboratory equipment and analytical issues to maintain smooth laboratory operations.
• Maintain accurate, detailed, and contemporaneous records of all laboratory work performed, in accordance with regulatory and internal documentation requirements.
• Contribute to meeting testing schedules by working collaboratively in a team-oriented environment and prioritizing tasks effectively.
• Read, interpret, and apply USP, EP, JP, and other compendial monographs, as well as analytical methodologies, to laboratory testing activities.
• Write standard operating procedures (SOPs), laboratory protocols, technical reports, memoranda, and other interdepartmental correspondence.
• Train and provide guidance to other laboratory personnel, helping them develop proficiency in general and advanced laboratory practices.
• Develop subject matter expertise in specific analytical techniques and laboratory practices and serve as a technical resource to the team.
• Use root cause analysis tools to investigate laboratory issues and deviations, and apply strong technical writing skills to complete laboratory investigation reports.
• Independently conduct and document laboratory investigations and serve as a backup for the laboratory supervisor when needed.
• Perform data review of analytical results to ensure accuracy, completeness, and compliance with applicable standards and procedures.

• 610 years of industry experience as a pharmaceutical chemist in a small-molecule environment.
• Bachelors or Masters degree in Chemistry or a closely related discipline.
• Strong hands-on HPLC experience, including method development and method validation.
• Experience with GC and other common analytical laboratory instrumentation.
• Demonstrated experience with analytical testing of small-molecule pharmaceutical drug substances and finished dosage forms.
• Proficiency in designing and executing analytical method transfer and validation protocols.
• Experience supporting cleaning validation activities, including protocol execution and report writing.
• Ability to read, interpret, and apply USP, EP, JP compendial monographs and analytical methodologies.
• Strong technical writing skills for authoring SOPs, protocols, reports, and investigation documents.
• Experience conducting and documenting laboratory investigations using root cause analysis tools.
• Ability to train and guide other laboratory personnel and act as a subject matter expert in laboratory practices.
• Strong data review skills with a focus on accuracy, completeness, and compliance.
• Demonstrated ability to troubleshoot laboratory instruments and analytical methods.
• Effective teamwork skills and the ability to work within a schedule-driven, collaborative laboratory environment.

• Empower chromatography data system proficiency is a plus.
• Experience in an animal health pharmaceutical environment is beneficial.
• Prior exposure to growing,…