QC Laboratory Instrument, Senior Specialist
Core
Senior specialist responsible for the lifecycle management, commissioning, and qualification of analytical instrumentation in a biotech QC laboratory for biologics manufacturing.
Role type
Senior Instrumentation Specialist (QC)
Builds
High potency biologics, Antibody Drug Conjugates (ADCs), and new biotechnology products
Domain
Biotechnology / Pharmaceutical Manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical Instrumentation, IQ/OQ/PQ, cGMP, Data Integrity, Root Cause Analysis, Vendor Management, Project Management, LIMS, Mass Spectrometry, HPLC/UPLC
Preferred skills
Advanced degree in Chemistry/Biochemistry/Engineering, Experience with Empower/Softmax Pro/GLIMS, Paperless laboratory environments
Technologies
Empower, Softmax Pro, GLIMS, LabX, MODA, Biovia, SAP, Veeva, LIMS
Responsibilities
Lead instrument commissioning and qualification (IQ/OQ/PQ) for new facility start-up, Develop and implement maintenance and calibration strategies, Lead root cause investigations for instrument-related deviations, Mentor junior instrument specialists, Ensure compliance with Data Integrity requirements, Author and approve commissioning protocols
Seniority
Senior, hands-on IC with leadership responsibilities
