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
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