Analytical Scientist, Bioassay

Alvotech; India; Remote; INR 600,000 - 1,200,000; Full time

Job summary

Alvotech is seeking an experienced analytical scientist to support the development of biopharmaceutical products, including monoclonal antibodies, in our India team. The role emphasizes data interpretation, scientific writing, and analytical development support across studies and documentation.

You will review analytical data, author qualification and validation reports, and collaborate with QA, regulatory affairs, and other technical functions to ensure compliance with ICH, FDA, USP, and GMP

Qualifications

• Degree in Biology, Biochemistry, Biotechnology or related field.
• Experience in analytical development, qualification or validation, QC.
• Strong knowledge of cell-based potency assays, binding assays, ELISA.
• Familiarity with ICH, FDA, USP and GMP requirements.

Responsibilities

• Review analytical data, studies and technical documentation.
• Author and review method qualification and validation protocols and reports.
• Assess deviations, unexpected results and out-of-spec investigations.
• Prepare reports supporting analytical similarity, stability and product characterization.
• Collaborate with laboratory scientists, QA, regulatory affairs and other technical functions.

Skills

Analytical development

Qualification & validation

Quality control

Bioanalytical assays

Data interpretation

Technical writing

Education

Bachelor's degree in Biology/Biochemistry/Biotechnology/Pharmaceutical Sciences

Job description

ABOUT THE ROLEWe are seeking an experienced analytical scientist to support the development of biological products, including monoclonal antibodies. This broad scientific role combines technical review, scientific writing, data interpretation and analytical development support.KEY RESPONSIBILITIESReview 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.QUALIFICATIONSDegree 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.Experience with HCP, residual DNA, residual Protein A or other process-related impurity assays is an advantage.Strong scientific judgment, data interpretation and technical writing skills, with a good understanding of relevant ICH, FDA, USP and GMP requirements.