QC Chemistry Lead

Responsibilities

• Lead the day-to-day management and oversight of the QC Chemistry Laboratory.
• Ensure efficient laboratory operations, regulatory compliance, and timely execution of testing activities.
• Cook up laboratory schedules and prioritize routine, batch release, expedited, and project-related samples.
• Oversee chemistry testing, including: Percent solids, Swell testing, Particle size analysis, Gel time, Burst and bubble testing, Aldehyde content, and Other applicable chemistry analyses.
• Review and approve sample execution and documentation within BAXLIMS.
• Ensure laboratory data integrity, accuracy, and compliance with GMP and quality-system requirements.
• Support Continued Process Verification activities through data collection, trending, analysis, and communication of results.
• Serve as the Chemistry subject-matter expert during internal and external audits.
• Lead laboratory 6S and safety initiatives.
• Support emergency-response activities and oversee laboratory organization, troubleshooting, risk mitigation, and procurement of testing materials.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline; advanced degree preferred.
• Prior experience working in a GMP-regulated pharmaceutical, biotechnology, or medical device QC chemistry laboratory.
• Prior leadership or supervisory experience.
• Hands-on expertise with percent solids, swell, particle size analysis, gel time, burst and bubble testing, aldehyde content, and related analytical techniques.
• Experience using BAXLIMS or a comparable laboratory information management system.
• Experience with sample workflow review, data verification, and documentation management.
• Ability to manage laboratory operations, support batch release, analyze CPV data, lead investigations, resolve discrepancies, and communicate with auditors and cross-functional stakeholders.