Analytical Scientist, Physicochemical
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Job Description
Analytical Scientist supporting analytical development and physicochemical characterization of monoclonal antibodies and other biological products. Reviewing data, validating methods, and preparing scientific reports in India.
Responsibilities:
- 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
Requirements:
- 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
- Experience with analytical similarity, stability or characterization studies is an advantage
- Strong scientific judgment, data interpretation and technical writing skills
- Good understanding of relevant ICH, FDA, USP and GMP requirements
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