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
- Cross functional coordination with all the inter departments for smooth flow of activities.
- Supporting to other QC functions (QMS, inter sectional activities) when required.
- Any activity assigned by supervisor/manager apart from the primary responsibilities
