Sudhir Kumar Joon

- Production of recombinant proteins, pDNA, and Vaccines via aseptic bio- fermentation processes -Plan and perform fed-batch production in 15L, 100L, and 1000L bioreactors -Use of Disc separator, depth filtration, homogenizer, and Diafiltration technologies in preparation for DSP -In-process Quality Assurance Responsibilities of In-process during Mfg. - Complete and ensure batch record review forms of all observations - Review, Complete and maintain a variety of documents required of a cGMP

- Setup of production machine (Granulator / Compactors and Tablet Press) for the batch production. - Weighing of raw materials, production of granules, tablets, film-coated tablets, capsules - Performing of in-process control tests of tablets hardness, weight, and rigidity - Batch documentation according to GMP guidelines

- Production of peptide hormone under sterile cGMP conditions (Compounding, microfiltration, aseptic Filling, Freeze-drying, and Crimping) - Preparation and operation of equipment according to written SOP examples include setup and sterilization - IPC sampling during the filling process - Conducting air and liquid (WIT) filter integrity tests before microfiltration of the bulk solution in compounding and filling processes.

Studienschwerpunkte: Molekulare genetik und Bioanalytics

Mikrobiologie, Molekularbiologie und Zellbiologie von menschlichen Zellen