Analytical Scientist, Bioassay

Alvotech; United States; Remote; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Alvotech is seeking an experienced analytical scientist to support the development of biological products, including monoclonal antibodies, in the United States. The role focuses on data interpretation, technical writing, and scientific assessment within analytical development programs.

You will review data, author qualification and validation documents, and collaborate with QA, Regulatory Affairs and other technical teams to ensure robust analytical strategies and product characterization.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Data interpretation

Technical writing

Scientific judgment

Collaboration

Ausbildung

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

Jobbeschreibung

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.