We’re #hiring! Anthem is looking for a Scientist/Sr.Scientist in Bioassays for Biologics.
RESPONSIBILITIES
•Method development, qualification, and execution for determination of process impurities - Host cell protein/HCP and Host cell DNA/HCD
•Method development, qualification, transfer of bioassays assays for biosimilars such as proliferation assays, cytotoxicity assays, apoptotic assays, cytopathic assays, ligand-binding assays, and kinetic assays
•Estimating relative biological potency of biosimilar molecules with respect to reference biologic
•CQA assessment, reference standard establishment, reference product characterization, and QTPP determination
•Preparing analytical technical reports to support regulatory submissions. Knowledgeable in FDA, EMEA, Indian, and ICH regulatory guidelines for potency and impurity profiling in biosimilars.
•Physicochemical characterization (HPLC, UPLC, RP-based methods) or secondary structure (CD) would be considered added advantage
QUALIFICATIONS
•Bachelors/Masters with 2 – 5 years of industrial experience in development of bioassays and determination of process impurities for biosimilars
Interested candidates can send their resumes to career@anthembio.com
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