Overview In this GMP-focused role, you perform analytical testing across drug substances, products, and related materials to ensure quality and compliance. You work with minimal supervision to execute validated methods, interpret data, and maintain data integrity. You will contribute to method transfer, investigations, and continuous improvement in a fast-paced pharmaceutical environment. This position offers the chance to support regulatory readiness and cross-functional communication while advancing analytical science. You will help ensure reliable data that supports product releases and development programs.
Responsibilities- Perform routine and non-routine GMP analytical testing of drug substances, products, raw materials, and stability samples
- Execute testing according to approved methods, specifications, SOPs, and GMP requirements
- Plan and organize lab activities to meet timelines with minimal supervision
- Document sample prep, reagents, instrument conditions, calculations, observations, and results with data integrity
- Review, analyze, and interpret data to ensure results are sound and traceable
- Operate and maintain standard lab equipment and instrumentation
- Troubleshoot methods and instrumentation; escalate when needed
- Identify atypical results and communicate issues via GMP processes
- Support investigations, CAPAs, change controls, and method-related assessments
- Assist in method transfer, qualification, verification, and validation activities
- Prepare and review GMP documents (notebooks, protocols, reports)
- Maintain control and traceability of standards, reagents, and laboratory materials
- Ensure safety and regulatory compliance in all activities
- Communicate results and risks to management and cross-functional teams
- Coordinate resources and testing activities to complete projects
- Contribute to continuous improvement in efficiency, data quality, and compliance
- Support regulatory inspections and internal audits
- Provide training or guidance to laboratory personnel
- Exercise sound judgment on independent action vs escalation
Key requirements- Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- Approximately 5 years of relevant analytical laboratory experience in pharmaceutical or biopharmaceutical GMP setting
- Experience performing analytical testing of synthetic pharmaceutical materials preferred
- Working knowledge of GMP, good documentation practices, and data integrity principles
- Ability to independently execute analytical procedures and generate accurate results
- Experience troubleshooting analytical instrumentation and methods
- Strong organizational skills to manage multiple lab activities and timelines
- Excellent written and verbal communication for documenting results and conveying conclusions
- strong written and verbal communication
- ability to work with minimal supervision
- problem-solving and troubleshooting
- HPLC/UPLC
- GC
- dissolution
