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Saurabh Gautam, PhD

Senior Manager ESO QA, Innovative Medicines and Large Molecules

Novartis

Country or State

Austria

Bio

I am a pharma industry professional with project & strategy management, CMC, manufacturing (GMP), and bioprocess development experience for NBEs, oncolytic viruses, viral vectors, vaccines, and biosimilars, with successful participation in 3 projects to clinics. On a personal level, I am interested in playing soccer, hiking, and cooking. Please find below further details and key points about my professional activities. -Leading the CMO (external supplier) and CMC activities for large scale GMP drug production, tech transfer, scale up, and manufacturing. -Leadership and collaborative skills with long-term expertise of supervision, coordination, conflict resolution, and team work as evidenced by 6+ international collaborations and 1 filed patent. -Efficient time management skills with high productivity in terms of completing projects within a defined time-frame resulting in 15+ successfully completed projects. -I have worked with and developed bioprocesses for viral vectors, vaccines, and proteins with an expertise in purification, chromatography, filtration (TFF, depth, diafiltration, nanofiltration, etc.), bioseparation, downstream, upstream processing, & formulation development. -Knowledge of current instrumentation and industrial trends with expertise in 20+ interdisciplinary techniques required for industrial manufacturing and bioprocess development of ATMPs, Biosimilars, and NBEs. -Profound understanding of •Bioanalytical •Biochemical •Biophysical •Spectroscopic (e.g. mass spectrometry approaches such as LC-MS) •Structural techniques, used for bioprocessing, manufacturing, and analytics of ATMPs (i.e. viruses), gene, and protein therapeutics. -Good communicator with proficiency in processing & presentation of information/data, scientific writing, and public speaking as demonstrated by interaction and fillings with national health authorities e.g., FDA, PEI, Swissmedic, NMPA etc. -Understanding of intermediate level German language (B1) as well. -Recipient of highly prestigious and competitive Marie Curie individual fellowship from European Commission.

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Current Position

Senior Manager ESO QA, Innovative Medicines and Large Molecules at Novartis

Degrees

Postdoctoral Research Scientist, Biochemistry

Skills