Analytical Scientist, Bioassay

IS10 Alvotech hf; India; Remote; INR 600,000 - 1,200,000; Full time

Job summary

Alvotech is seeking an experienced analytical scientist to support development of biological products, including monoclonal antibodies. You will review analytical data, author method qualification/validation protocols, and contribute to scientific reports.

Join a global biotech company and collaborate with QA, Regulatory and other technical teams to advance biosimilar programs and ensure adherence to ICH, FDA, USP and GMP guidelines.

Qualifications

• 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.
• 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.

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.

Education

Degree in Biology, Biochemistry, Biotechnology, Pharmaceutical Sciences or a related field

Job description

ABOUT THE ROLE

We 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 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 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.

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide.

Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars.

We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged.

Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do.

Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business.

Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide.

If you have any technical issues, please contact: [e-mail]