Working with National Institute of Biologicals, under the aegis of Ministry of Health & Family Welfare, Govt. of India
Ability to multitask across platforms (QC, Informatics & Accreditation services). About 20 years experience in QC/QA of Biologics (Biotherapeutics - mAbs, enzymes, Immunodiagnostics - Infectious disease marker testing) in a well regulated, fast paced environment for Biologics. Keen observer and follower in the global developmental studies & regulations in biologics. Application of BIOSTATISTICS & INFORMATICS to development of bio-therapeutics, QbD-GMPs.
Expertise includes development of in-house method validation protocols, SOPs, assistance in managing labs compliant wit...
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