QC Chemistry Lead

Responsibilities

• Lead the day-to-day management and oversight of the QC Chemistry Laboratory, ensuring efficient operations, compliance, and timely execution of testing activities.
• Cook up laboratory scheduling and prioritization of routine, batch release, expedited, and PDO/project-related samples for testing such as % Solids, Swell, Particle Size Analysis, Gel Time, Burst/Bubble Testing, Aldehyde Content, and other chemistry analyses.
• Review and approve sample execution and documentation within BAXLIMS, ensuring data integrity, accuracy, and compliance with GMP and quality system requirements.
• Support Continued Process Verification (CPV) activities through data collection, trending, analysis, and communication of results to cross-functional stakeholders.
• Serve as the Chemistry SME during internal and external audits, lead laboratory 6S and safety initiatives, participate as an Emergency Response Team (ERT) member, and oversee laboratory organization, troubleshooting, risk mitigation, and procurement of laboratory testing materials.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
• Prior professional experience in a GMP-regulated pharmaceutical, biotechnology, or medical device QC chemistry laboratory, including leadership or supervisory responsibilities.
• Strong hands-on expertise with chemistry testing methods including % Solids, Swell, Particle Size Analysis, Gel Time, Burst/Bubble Testing, Aldehyde Content, and related analytical techniques.
• Proven experience with BAXLIMS (or comparable LIMS platform), including sample workflow review, data verification, and documentation management.

Qualifications

• Demonstrated ability to manage laboratory operations, support batch release activities, analyze CPV data, lead investigations and discrepancy resolution, and communicate effectively with cross-functional teams, auditors, and external stakeholders.