R&D - Upstream, Biologics

About Us:

Aurigene Pharmaceutical Services Limited is a leading contract research, development, and manufacturing organization (CRO/CDMO) and a long-term partner providing end-to-end solutions thereby accelerating innovation. With a strong legacy of services in discovery chemistry, discovery biology, development and manufacturing. We are ideally positioned to serve global pharma and specialty companies worldwide by providing truly integrated services. We are established in the NBE discovery services and now expanding our Large Molecule capabilities in development and manufacturing. We are equipped with the state of the art CDMO biologics facility which will cater to global Biopharma companies for development of Antibodies & Protein Therapeutics based at Hyderabad.

Qualification:

Responsibilities:

• To execute cell culture activities related to process development for expression of recombinant proteins and mAbs.
• To involve in media and feed preparation.
• To execute the experiment for clonal evaluation, media and feed screening, feed optimization using DOE.
• To execute assign experiment for process optimization using shake flask, amber15 and lab scale bioreactors.
• To involve in cell bank preparation.
• To execute process optimization for microbial platform to express recombinant proteins.
• To involve in the Technology Transfer from R&D to mAbs manufacturing facility.
• To maintain the experimental data in Electronic Laboratory Notebook (ELN) / LNB (Physical).
• To draft the documents (URS, SOP, Protocol etc.) in DocHub or manual format.
• To initiate and close the deviations/incidents/change controls and prepare CAPAs reports.
• Work on administration related to SAP (Material creation, Material extension and PR raise)