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

Roles and Responsibilities

1. Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
2. Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
3. Performing stability related activity.
4. Receipt of in process, DS, reserve samples and stability samples and storage at QC location.
5. Preparation, qualification and life cycle management of cell banks used in bioassays.
6. Planning and review In-Process, finished product and stability sample testing of monoclonal antibodies and biosimilars and reporting the results.
7. 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.
8. Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
9. Planning and performing (Testing) of method transfer, method validation and study samples.
10. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
11. Reporting and investigation of Incidents, OOS, OOT and Deviation.
12. Supporting Operational Excellence, 5S in Quality control Lab.
13. Calibration of analytical weighing balance, pH meter etc.
14. 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