Job Description
Job Description
Role Summary
The Analytical Scientist will perform analytical testing of pharmaceutical products, drug-device combination products, and materials supporting current products, new product development, stability studies, and analytical services. Responsibilities include chromatographic analysis, method development and validation, and GMP-compliant documentation.
Responsibilities
- Perform wet chemistry and instrumental testing using HPLC, GC, dissolution, and texture analysis.
- Analyze raw materials and finished products according to approved methods and specifications.
- Use Empower or similar chromatography data systems.
- Document and archive results using electronic laboratory notebooks and LIMS in compliance with GMP.
- Support method development, validation, stability, and product understanding studies.
- Prepare technical documents, including methods, protocols, reports, work instructions, and specifications.
- Support laboratory equipment qualification, calibration, and maintenance.
- Apply critical thinking, problem-solving, and data analysis skills.
- Prioritize multiple projects and adapt to changing priorities.
- Maintain a strong commitment to laboratory safety and quality.
- Work effectively both independently and as part of a team.
Basic Qualifications
- Bachelor’s degree or higher in Chemistry or a related science discipline.
- Basic understanding of GMP.
- At least 1 year of analytical testing experience or equivalent laboratory coursework.
Preferred Qualifications
- Experience with Empower or similar chromatography data acquisition systems.
- Experience with GMP-compliant laboratory documentation.
- Demonstrated technical writing and data analysis skills.