Analytical Scientist, Bioassay

Overview

Support the development of biological products, including monoclonal antibodies, through 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 Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences or a related field.
• Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical activities.
• Strong knowledge of cell-based potency assays, binding assays, ELISA and related bioanalytical techniques.
• Strong scientific judgment, data interpretation and technical writing skills.
• Good understanding of relevant ICH, FDA, USP and GMP requirements.

Nice to have

• Experience with HCP, residual DNA, residual Protein A or other process-related impurity assays.

Details

• Location: India Home Office.