Manager, QC Analytical Instrument Operations, US Site (Hopewell, NJ)

Role Summary

Manager, QC Analytical Instrument Operations, US Site (Hopewell, NJ) responsible for managing all Quality Control laboratory instrumentation and metrology activities to support GMP manufacturing, testing, and release of materials, intermediates, and finished products under regulatory guidelines. Ensures GMP manufacturing readiness by maintaining accuracy, calibration, and reliability of laboratory instruments, minimizing downtime and ensuring compliance.

Responsibilities

• Manage/perform the calibration, verification, and qualification of basic laboratory instruments and equipment, including balances, pH meters, centrifuges, etc.
• Provide dedicated support for equipment life cycle management—calibration and maintenance scheduling, and documentation
• Manage vendor contracts and relationships for equipment needing specialist service, including HPLC, GC, spectrophotometers
• Ensure all calibration activities comply with regulatory guidelines (e.g., cGMP, USP/EP, etc.)
• Maintain detailed records of calibration, maintenance, and repair activities, including calibration certificates and reports
• Support the qualification of new laboratory instruments, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Generate and review qualification protocols and reports
• Manage the inventory of calibration standards and supplies
• Perform routine operations, including instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, record keeping, etc.
• Lead investigations of equipment out-of-tolerance (OOT), discrepancies, errors, and failures
• Implement corrective actions and preventive actions (CAPAs)
• Assist in the preparation for internal and external GMP audits related to instrument calibration
• Train other junior level analysts and new hires
• Subject matter expert in one or more areas of required testing
• Undertake any other duties as required

Qualifications

• Required: Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required
• Preferred: Bachelor’s in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, Engineering or related scientific discipline

Skills

• Proficiency in calibrating and troubleshooting a variety of laboratory instruments
• Working knowledge and experience with laboratory instrumentation, such as GC, HPLC, UPLC, titrators, Raman, UV spectrophotometer, FTIR, PCR, etc.
• Working knowledge of laboratory operations and workflows in the pharmaceutical industry
• Working knowledge with USP/EP, ICH Guidelines and cGMP/EU GMP
• Strong knowledge of regulatory requirements for data management and compliance
• Track record and skills/experience gained within a similar position at a similar level
• Strong leadership/team management skills and experience
• Credible and confident communicator (written and verbal) at all levels
• Strong analytical and problem-solving ability
• Hands-on approach with a can-do attitude
• Ability to prioritize with good time management
• Excellent attention to detail and ability to work accurately in a busy environment
• Self-motivated with the ability to work proactively using own initiative
• Committed to learning and development

Education

• Not separately listed beyond the qualifications section; education requirements are included in the Qualifications section above.

Additional Requirements

• Not specified beyond the role responsibilities and qualifications.