This is a fully remote position, open to applicants in India.

📋 Description

• Evaluate and critically analyze analytical data, studies, and technical documentation.

• Create and review protocols and reports for method qualification and validation.

• Identify and document deviations, unexpected outcomes, and investigations of out-of-spec results that occur during analytical studies.

• Prepare scientific reports and assessments that support analytical similarity, comparability, stability, forced degradation, and product characterization.

• Work collaboratively with laboratory scientists, Quality Assurance, Regulatory Affairs, and other technical departments.

⛳️ Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.

• Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical processes.

• Comprehensive knowledge of physicochemical techniques such as HPLC/UHPLC, capillary electrophoresis, and UV/Vis, preferably in relation to monoclonal antibodies or other therapeutic proteins.

• Familiarity with analytical similarity, stability, or characterization studies is advantageous.

• Excellent scientific judgment, data interpretation abilities, and technical writing skills.

• Solid understanding of relevant ICH, FDA, USP, and GMP regulations.