About Anthem Biologicals: An SBU of Anthem Biosciences focusing on development & manufacturing of wide range of biologicals like Therapeutic enzymes, Probiotics, Specialty Vitamins, Peptides and Biosimilars. We have set up state
of the art, GMP compliant infrastructure to support global companies in CRO, CDMO & CMO space and to take our own biological products to the global markets. We have established partnerships with global biopharmaceutical companies and catering to the needs of the regulated markets.
Scientist/ Sr. Scientist – Bioassay
We’re hiring! Anthem is looking for a Scientist/Sr. Scientist with 2-5 years of industrial experience for our Bioassay team.
Candidate should have:
- Qualification: Bachelors /Masters with 2-5 years of industrial experience in development of bioassays and determination of process impurities for biosimilars.
- Ability to work extensively with cross-functional teams under tight timelines.
- Excellent team player and verbal/written communication skills.
- Extensive experience in 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: Assays could include, but not limited to proliferation assays, cytotoxicity assays, apoptotic assays, cytopathic assays, ligand-binding assays, and kinetic assays.
- CQA assessment, reference standard establishment, reference product characterization, and QTPP determination.
- Assist in authoring analytical technical reports to support regulatory submissions. Knowledgeable in FDA, EMEA, Indian, and ICH regulatory guidelines for potency and impurity profiling in biosimilars
- Support process analytics for multiple programs and ensure timely delivery of projects.
- Train junior colleagues and manage the delivery of results in a timely manner.
- Work with the team lead and assist in the execution of activities.
Interested candidates can send their resume to firstname.lastname@example.org with ‘Assay Biologist‘ as the subject.