Senior Executive - QC Biosimilars ( Bioassy)

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.

https : / / www.bioconbiologics.com

Education Qualification : MSc

Experience : 4-6 years with Mandatory Bioassay Experience preferred.

Roles and Responsibilities

• Ensure & 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 transfer and study, Review of usage log books and Observation data sheets.
• Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
• Planning and performing (Testing) of method transfer, method validation and study samples.
• Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
• Reporting and investigation of Incidents, OOS, OOT and Deviation.
• Supporting Operational Excellence, 5S in Quality control Lab.
• Calibration of analytical weighing balance, pH meter etc.
• Various monitoring such as lab and equipment and cleaning of labs activities

Secondary responsibilities