Sr. Quality Control Scientist
Core
Develop, validate, and optimize analytical assays for quality control in biopharmaceutical chemistry.
Role type
Senior IC quality control scientist (chemistry)
Builds
Production quality control assays and validation reports for biopharmaceutical products
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC-based assay development, assay validation, method transfer, technical troubleshooting, regulatory compliance review, analytical report review, training delivery
Preferred skills
Cell or gene therapy experience, PhD in relevant field
Technologies
HPLC
Responsibilities
Perform assay development, characterization, optimization, transfer, and validation; Review new test procedures and evaluate new methodologies; Facilitate assay transfer from R&D to business partners; Set product specifications; Participate in technical troubleshooting and problem investigation; Review analytical and process validation reports for technical correctness and regulatory compliance; Participate in training programs for analysts
