Analytical Scientist, Physicochemical

Alvotech; Kolkata District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Alvotech is seeking an experienced analytical scientist to support development and characterization of biopharmaceutical products, including monoclonal antibodies. The role involves data interpretation, scientific writing, and cross-functional collaborative work in a GMP environment.

The ideal candidate has a degree in a related field and hands-on experience with HPLC/UHPLC, capillary electrophoresis, and UV/Vis, with knowledge of regulatory requirements for biopharmaceuticals.

Qualifications

• Degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Experience in analytical development, qualification or validation, quality control, or related biopharmaceutical activities.
• Strong knowledge of physicochemical methods used for monoclonal antibodies or therapeutic proteins.
• Familiarity with ICH, FDA, USP and GMP requirements.

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.
• Prepare scientific reports supporting analytical similarity, stability, and product characterization.
• Collaborate with laboratory scientists, QA, Regulatory Affairs and other functions.

Skills

Analytical data interpretation

Technical writing

Data review

ICH GMP understanding

Education

Degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related fields

Tools

HPLC/UHPLC

Capillary electrophoresis

UV/Vis

Job description

About The Role

We are seeking an experienced analytical scientist to support analytical development and characterization of biological products, including monoclonal antibodies. This broad scientific role combines technical review, scientific writing, data interpretation and analytical development support.

Key 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.

Qualifications

• 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, with a good understanding of relevant ICH, FDA, USP and GMP requirements.