Assistant Manager - QC Biosimilar

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 : MSc

Experience : 4 - 10 years with Mandatory Mol Bio Experience preferred.

Roles and Responsibilities

1. Adherence to cGMP (Current Good Manufacturing Practice), cGLP(Current Good Laboratory Practice) and GDP (Good Documentation Practice).

2. Qualification of Instruments and Equipment (IQ / OQ / PQ) and Facility readiness.

3. Receipt of in process, DS, reserve samples and stability samples, Sample splitting and storage at designated storage location.

4. Planning and performing of In-Process, Finished product (DS) and Stability samples, and reporting the results.

5. Discard of the released batch samples in a timely manner as per waste management SOP.

6. Receipt of chemicals / reagents / consumables, labelling and storage in segregated storage place. 7. Review of analytical reports of In-process, Finished product, Stability, Method Validation, Method Transfer and Study, Review of usage logbooks 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, and equipment status etc.

11. Reporting of Incidents, OOS, OOT and Deviation. Support in closure of the QMS elements.

12. Operation, and monitoring of Analytical equipment. Coordinate with Engineering for timely internal / external calibration, requalification, Preventive maintenance and AMC of equipment.

13. Supporting Operational Excellence, 5S in Quality control Lab.

14. Work for the goals given as part of strategic initiatives

15. Monitoring of EMS / Equipment parameters (Strip chart, Temperature, RH, Differential pressure, LN2 levels and CO2 levels etc.) and reviewing the reports.

16. Timely update to supervisor on inventory of chemicals / reagents / consumables

17. Involvement in Fumigation and Cleaning activities of laboratory

18. Various monitoring such as lab and equipment and cleaning of labs activities.

Secondary responsibilities :

1. Any activity assigned by supervisor / manager apart from the primary responsibilities.

2. Supporting to other QC functions when required.

3. Any activity assigned by supervisor / manager apart from the primary responsibilities.