16 Stanford Laboratories Jobs

Role & responsibilities

• Analytical Method Validation (AMV): Perform method validation activities, including designing validation protocols, executing validation studies, and documenting results for analytical methods used in raw materials, in-process testing, and finished product testing.
• Method Transfer: Participate in the transfer of analytical methods from R&D to QC and from QC to production environments, ensuring all validation steps are completed in accordance with GMP and regulatory guidelines.
• Data Analysis: Analyze and interpret data from method validation and verification studies, ensuring that all analytical methods meet the required specifications, accuracy, precision, and robustness.
• Compliance & Documentation: Ensure all method validation documentation is compliant with GMP, GLP, and regulatory requirements. Maintain accurate records of validation protocols, reports, and outcomes.
• Troubleshooting: Investigate any issues or deviations during method validation and provide support in troubleshooting analytical methods or equipment failures.
• Regulatory Compliance: Keep abreast of current regulatory requirements (FDA, EMA, ICH, etc.) and ensure that all methods and validations are conducted in compliance with industry standards.
• Training: Assist in training QC staff on new or modified analytical methods, validation processes, and regulatory requirements related to method validation.
• Instrument Qualification: Participate in the qualification and calibration of analytical instruments used in method validation and routine testing.
• Continuous Improvement: Contribute to the continuous improvement of analytical methods and validation processes to ensure efficiency, accuracy, and compliance.

Preferred candidate profile

• Education: Bachelors or Master’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field.
• Experience: Minimum of 5 to 7 years of experience in analytical method validation, method development, or analytical testing in the pharmaceutical industry.
• Skills:
• Strong understanding of analytical techniques such as HPLC, GC, UV-VIS, FTIR, etc.
• Experience with analytical method validation in compliance with ICH Q2(R1) and other regulatory guidelines.
• Proficiency in statistical analysis and data interpretation.
• Knowledge of GMP, GLP, and FDA/EMA regulations related to analytical testing and method validation.
• Attention to detail, strong problem-solving skills, and the ability to work under pressure.
• Excellent written and verbal communication skills, with the ability to prepare clear and concise technical documentation.
• Certifications: Certification in Analytical Chemistry or related fields is a plus.