Analytical Scientist, Physicochemical

Overview

Analytical scientist supporting analytical development and characterization of biological products, including monoclonal antibodies, combining technical review, scientific writing, data interpretation and analytical development support.

What you'll do

• Review and critically assess analytical data, studies and technical documentation.
• Author and review method qualification and validation protocols and reports.
• Assess and document deviations, unexpected results and out of spec investigations arising during analytical studies.
• Prepare scientific reports and assessments supporting analytical similarity and comparability, stability, forced degradation and product characterization.
• Collaborate with laboratory scientists, Quality Assurance, Regulatory Affairs and other technical functions.

What you'll need

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related fields.
• Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical activities.
• Strong knowledge of physicochemical methods such as HPLC/UHPLC, capillary electrophoresis and UV/Vis, preferably applied to monoclonal antibodies or other therapeutic proteins.
• Strong scientific judgment, data interpretation and technical writing skills.
• Good understanding of relevant ICH, FDA, USP and GMP requirements.

Nice to have

• Experience with analytical similarity, stability or characterization studies.

Details

• Location: India, home office.