Analytical Scientist, Bioassay

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. Originally posted on Himalayas