About the role
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.