Scientist III, Analytical Development/Data Reviewer

Role Summary

The Data Reviewer within the Analytical Development team supports clinical programs by ensuring accuracy, completeness, and integrity of analytical data. Responsible for independent review of raw data, chromatographic results, and analytical documentation to ensure compliance with internal procedures, industry best practices, and regulatory expectations.

Responsibilities

• Data Review: Perform detailed review of analytical data packages, chromatographic data (e.g., Empower), calculations, laboratory notebooks and final reports.
• Compliance Assurance: Ensure data is recorded and reported in compliance with internal SOPs, cGMP, ICH, and FDA 21 CFR Part 11 requirements.
• Issue Identification: Identify and escalate discrepancies, inconsistencies, or deviations in data or documentation.
• Collaboration: Work closely with analysts and management to resolve data issues and ensure timely completion of reviews.
• Instrument Support: Support instrument calibration, maintenance, and troubleshooting in collaboration with lab staff.
• Lab Operations Assistance: Assist with lab operations, including reagent preparation, equipment verification, and documentation updates.
• Audit Readiness: Ensure data packages are complete, well-organized, and inspection-ready to support internal and external audits.
• Process Improvement: Contribute to continuous improvement initiatives related to data review processes and documentation practices.
• Training Support: Assist in training team members on data integrity principles and review expectations.
• Other Duties: Perform additional tasks as assigned to support the Analytical Development function.

Qualifications

• Bachelor‚Äôs degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 6-8 years of experience in a GMP-regulated analytical laboratory or quality environment.
• Strong working knowledge of data integrity regulations and guidance (e.g., FDA, EMA, MHRA, WHO).
• Proficiency in chromatographic software (e.g., Empower) and data analysis tools (e.g., Excel, JMP).
• Excellent attention to detail, organizational skills, and communication abilities.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Hands-on experience with analytical instrumentation and lab operations, preferred.
• Familiarity with inhalation drug delivery systems and aerosol testing is a plus.
• Experience supporting audit preparation and regulatory inspections is a plus.