Analytical Team Leader
Core
Lead QC analytical testing operations, ensuring compliance with GMP standards and supporting method transfers to maintain product quality.
Role type
Senior IC Quality Control Team Leader (Analytical)
Builds
Production quality control testing and validated analytical methods
Domain
Pharmaceutical/Biotech Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP compliance, analytical instrumentation (HPLC/UPLC, LC-MS, GC-MS, IC, ICPMS, UV, FTIR), LIMS proficiency, method transfer execution, OOS/OOT investigation, CAPA management, regulatory knowledge (ICH, pharmacopeia), team leadership, project management
Preferred skills
Industry certifications in GMP/GDP, experience with Empower/TrackWise, statistical analysis tools, environmental monitoring knowledge
Technologies
HPLC/UPLC, LC-MS, GC-MS, IC, ICPMS, UV, FTIR, pH Meters, Osmometers, Rheometers, Empower, LIMS, TrackWise
Responsibilities
Lead analytical method transfer activities from R&D or external sites; Ensure timely testing of raw materials, in-process, stability, and finished product samples; Participate in investigations related to OOS, OOT, Deviations, and CAPA; Ensure analysts are trained and qualified on analytical techniques and laboratory systems; Manage lab equipment calibration and maintenance programs
Seniority
Senior, hands-on IC
