Principal Scientist-Quality Control, Instrumentation
Core
Monitor, coordinate, and maintain cGMP Quality Control instrumentation to ensure data accuracy and consistency with SOPs in a pharmaceutical manufacturing environment.
Role type
Principal Scientist-Quality Control, Instrumentation
Builds
Production quality control data and validated analytical results for drug development and delivery
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, Good Documentation Practices (GDP), Good Laboratory Practices (GLP), Lean Six Sigma, aseptic technique, clean room procedures, equipment lifecycle management, vendor management, technical documentation, data self-review, training leadership, troubleshooting
Preferred skills
Experience with Agilent, Waters, and Thermo HPLC/UHPLCs, LC/MS, GC, Sciex PA800 Plus, Protein Simple iCE3, Biotech and Molecular Devices Plate Washers and Plate Readers, Applied BioSystems 3500xL and 7500 Fast, Controlled Temperature Units, pH Meters, Balances, Pipettes
Technologies
Agilent, Waters, Thermo, Sciex, Protein Simple, Biotech, Molecular Devices, Applied BioSystems
Responsibilities
Monitor and coordinate instrument installation and maintenance; Operate basic, moderately complex, and complex cGMP Quality Control equipment; Manage all aspects of laboratory equipment lifecycle; Manage all aspects of equipment vendor management; Prioritize and schedule activities to meet deadlines; Interact as an SME for internal and external entities; Lead training of specific analytical instruments and processes; Perform self-review of analytical data for accuracy and consistency with SOP; Perform general lab housekeeping in adherence to 5S standards; Complete routine and preventive maintenance on equipment; Maintain and troubleshoot Quality Control equipment; Write technical documents
Seniority
Principal, hands-on IC with strategic vendor and lifecycle management
