Senior Technical Analytical Specialist
Core
Primary technical authority for analytical laboratory operations, ensuring compliance, verification, and infrastructure support for routine and advanced testing in pharmaceutical manufacturing.
Role type
Senior Technical Analytical Specialist
Builds
Analytical testing services and compliant laboratory operations for Active Pharmaceutical Ingredients
Domain
Pharmaceutical manufacturing / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC, GC, KF, dissolution, MS, XRD, method development, method transfer, method validation, troubleshooting, cGMP, GLP, ICH/CDER, FDA/HPRA, EHS, SOP authoring, equipment qualification, audit support, CAPA development, continuous improvement
Preferred skills
Mentorship of analysts, workflow optimization, process modernization, safety hazard resolution
Technologies
HPLC, GC, KF, dissolution testers, MS, XRD
Responsibilities
Provide analytical testing and technical support for routine, non-routine, and advanced applications; Lead compliance verification for analytical results, methods, equipment, records, and data; Author, update, and maintain SOPs, protocols, and technical records; Oversee laboratory infrastructure, including asset management, equipment purchasing, qualification, maintenance, and workflow optimization; Perform advanced troubleshooting, technical investigations, and support method validation, transfer, and integration activities; Mentor and coach analysts and project teams on compliance, verification, laboratory operations, equipment use, and best practices; Support internal and external audits, regulatory inspections, CAPA development, and quality system initiatives; Drive continuous improvement in compliance, documentation, workflow efficiency, process modernization, and laboratory systems; Ensure equipment is qualified, maintained, and used in line with compliance and safety standards; Conduct calculations, report findings, and escalate analytical or verification issues supporting high-impact investigations and improvement projects; Identify and help resolve safety hazards and non-compliance issues in coordination with EHS and Lab Management; Maintain accurate, complete, and current records for all laboratory activities; Complete handover of validated analytical methods to QC, ensuring smooth transfer of knowledge, protocols, and compliance requirements.
Seniority
Senior, hands-on IC
