QC Senior Scientist- Raw Materials
Core
Perform laboratory testing, method transfers, validations, and investigations for raw materials used in manufacturing life-changing therapies.
Role type
Senior IC QC Scientist (Raw Materials)
Builds
Raw material batches for pharmaceutical/biotech manufacturing
Domain
Pharmaceutical/Biotechnology Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP laboratory experience, analytical testing, method validation, technical writing, data analysis, troubleshooting, equipment setup, root cause analysis, training/mentoring, cross-functional collaboration
Preferred skills
MS or PhD degree, pharmaceutical compendia knowledge, LIMS/TrackWise/DMS experience, continuous improvement initiatives
Technologies
LIMS, TrackWise, DMS, electronic laboratory notebooks, Microsoft Office
Responsibilities
Perform laboratory testing for method transfers and validations; Author and review technical documents and protocols; Support analytical method transfers and implementation; Review analytical data for GMP and data integrity compliance; Lead or support validation, transfer, and investigation activities; Set up and verify laboratory equipment and testing systems; Investigate laboratory events and support corrective actions; Train and mentor colleagues on laboratory methods; Drive continuous improvement initiatives; Act as SME on Raw Material compliance for audits and stakeholder support
Seniority
Senior, hands-on IC