Senior Executive

1 week ago


Bengaluru, India Biocon Biologics Full time

Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently. Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.Education Qualification: MScExperience: 4-6 years with Mandatory Bioassay Experience preferred.Roles and ResponsibilitiesEnsure & Implementation of Data Integrity Culture in Quality Control Lab.Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).Performing stability related activity.Receipt of in process, DS, reserve samples and stability samples and storage at QC location.Preparation, qualification and life cycle management of cell banks used in bioassays.Planning and review In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.Review of analytical reports of In process, finished product, stability, method validation, method


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