Job Description
This role is responsible for developing, optimizing, and validating analytical methods to support chemistry, stability, and related testing programs. The position applies industry-standard instrumentation and scientific expertise to generate accurate, precise, and compliant analytical data, supporting GMP compliance.
Key Responsibilities
- Provide technical expertise in the development, optimization, qualification, and validation of analytical methods to support product development, formulation studies, material release, and in-process monitoring.
- Design and execute method development and validation activities across multiple stages of product and process development.
- Develop, validate, transfer, and document analytical methods; generate and author validation protocols and final reports.
- Design validation studies in compliance with ICH and applicable regulatory guidelines, identifying critical method parameters beyond minimum requirements when necessary.
- Perform chemical and physical analyses on raw materials and finished products using standard analytical instrumentation, including HPLC, LC-MS, GC, GC-MS, MS, and ICP-MS.
- Review analytical data, laboratory notebooks, and results prior to data release; collect, analyze, and interpret data accurately.
- Review, author, and improve laboratory SOPs and forms to ensure clarity, compliance, and proper record retention.
- Support investigations, including Out-of-Specification (OOS) results, and guide appropriate re-testing strategies.
- Maintain analytical laboratory equipment through routine standardization, maintenance, and support of IQ/OQ/PQ and preventive maintenance activities.
- Support continuous improvement initiatives to enhance laboratory efficiency, quality, and compliance.
- Monitor laboratory inventory required for validation activities and prepare purchase requests as needed.
- Collect and maintain Safety Data Sheets (SDS) for chemicals and reagents.
- Write SOPs and train laboratory personnel on analytical methods and best practices.
- Participate in and support laboratory safety training programs.
- Operate laboratory equipment safely and in accordance with established procedures.
- Perform additional related duties as assigned.
Qualifications
- Bachelor's or Master's degree in a relevant scientific discipline (e.g., Chemistry, Biochemistry, Biological Sciences, Bioengineering, or related field).
- Minimum of 5 years of experience in analytical assay development and optimization.
- Demonstrated experience in analytical method development, optimization, and validation.
- Hands-on experience with HPLC, LC-MS, GC, GC-MS, and ICP-MS is required.
