Sr. Quality Control Scientist (Chemistry)
Core
Develop, validate, and optimize analytical assays for quality control in a biopharmaceutical setting, supporting release and stability testing.
Role type
Senior IC quality control scientist (chemistry)
Builds
Production quality control assays and validated test procedures
Domain
Biopharmaceuticals / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Note: Correcting the mapping logic based on the actual content. The role involves physical lab work and assay development. Let's map to 'physical/clinical work' or a more generic 'product features' if strictly following the list. Actually, the list provided in the prompt instructions is fixed: 'production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work'. Assay development and validation in a QC lab is best mapped to 'physical/clinical work' as it involves hands-on lab procedures, or potentially 'product features' if viewed as creating the testing feature. Given the context of 'physical/clinical work' usually implying patient-facing or heavy equipment, and this being lab-based, 'physical/clinical work' is the closest fit among the limited options for hands-on lab science, though 'product features' is also a stretch. Let's select 'physical/clinical work' as it implies hands-on technical execution in a regulated environment, or 'product features' if we consider the assay a feature. However, standard interpretation for lab scientists in this schema often falls under 'physical/clinical work' due to the hands-on nature. Let's use 'physical/clinical work'.)
Required skills
HPLC-based assay development, assay validation, method transfer, technical troubleshooting, regulatory compliance documentation, analytical report review, training and mentoring
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 between R&D and business partners; set product specifications; participate in technical troubleshooting and investigations; review technical documents for regulatory compliance; conduct training programs for analysts
Seniority
Senior, hands-on IC
