Senior Manager, QC Chemistry

Key Accountabilities/Core Job Responsibilities

• Lead and develop QC Chemistry team; set priorities, build schedules, run tier huddles, and ensure coverage/cross-training
• Hands-on (~50%) lab leader supporting chromatography testing, troubleshooting, record approvals, and bench mentoring
• Own analytical method lifecycle (readiness, validation/verification/transfer); author/review protocols, reports, and change control
• Serve as QC SME for HPLC/UPLC and core analytical techniques (e.g., UV/Vis); support biologics assays (e.g., CE-SDS, icIEF, potency) as needed
• Ensure GMP/ALCOA+ data integrity & GDP; review/approve ELN/LIMS entries; maintain audit readiness and responses
• Lead OOT/OOS/deviation investigations, root cause, and CAPAs; verify effectiveness and drive timely closure
• Act as QC lead for method transfers, coordinating with AD/CMC/Manufacturing; define readiness and execute in QC
• Oversee instrument lifecycle (URS inputs, IOQ/PQ, calibration/PM, training, release-to-use) with ENG/vendors
• Drive operations & KPIs (TAT, investigation cycle time, schedule adherence); standardize SOPs/templates and oversee routine QC testing, stability, and sample management
• Lead direct report(s) through goal setting, development planning, training compliance, and ongoing performance feedback

Qualifications/Skills

• Typically requires a BS in Chemistry, Biochemistry, or related field and 8+ years of GMP QC experience (pharma/biotech), including 3+ years of people management experience
• Strong hands-on chromatography experience (HPLC/UPLC required)
• Prior experience leading or mentoring small teams
• Experience with analytical method validation, transfer, and troubleshooting
• Strong knowledge of GMP, data integrity (ALCOA+), and QC documentation practices
• Experience with OOS/OOT investigations, root cause analysis, and CAPAs
• Familiarity with CDS/ELN/LIMS systems (e.g., Empower, OpenLab)
• Biologics analytical experience (e.g., CE-SDS, icIEF, potency) is a plus, not required