Analytical Scientist, Bioassay
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Job Description
Analytical Scientist supporting bioassay development, validation, and characterization of biopharmaceutical products. Reviewing analytical data and authoring scientific and regulatory documentation from an India home office.
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
Requirements:
- 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
- Strong scientific judgment, data interpretation and technical writing skills
- Good understanding of relevant ICH, FDA, USP and GMP requirements
- Experience with HCP, residual DNA, residual Protein A or other process-related impurity assays is an advantage
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