Dr. Narayan P Email & Phone Number

Passionate, creative, dedicated, and highly motivated with experience in the biologics industry and a proven record of leading and solving challenging projects by working both independently and in teamsdriven leader with a proven track record as site lead/project leader in biologics strategic and tactical thinking, effective communication, asset management and prioritization, project leadership.Specialties Biologics,Vaccines and Injectables-Operations Clinical to Commercial,Technology Transfer,Cell and Gene therapy, MS&T,Process Development,CMC Submissions(Bio similar, manufacturing strategies for commercial vaccine production,Project Execution Plans,Cross Functional Leadership and Business ManagementStrong scientific background. Passionate about viable and sustainable manufacturing and commercialization of Biologics,Injectables and Vaccines for global use.Leading with responsibility to move various candidate biologics products from preclinical to clinical and commercial manufacturing. Responsible for pipeline product prioritization, project planning and debottlenecking (technical as well as logistical), and effective capacity utilization. Responsible for interactions with potential external partners, and build collaborations with a win-win philosophyManaging a group of 70 technical professionals in the manufacturing area of the plant. Responsibilities include management of 24/7 operations, resolution of time-critical roadblocks, planning activities short/intermediate/long term, and making sure that production targets are met in an aggressive environment. The plant generates over 1000 million of sterile injectable units, and is the largest manufacturing plantEstablish and lead Process Development and manufacturing sciences at Center for Breakthrough MedicinesServe as lead subject matter expert in advanced therapy manufacturing sciencesDesign and oversee experiments in collaboration with Process Development, Analytical Development, and other teams to support for manufacturingIdentify and implement process improvements during early and late-stage clinical manufacturing and associated technical transfersCollaborate with Process Development, Manufacturing, and Analytical Development on actions necessary in preparation for late-stage trials and filing of BLASupport production related investigations, ensuring compliance with internal standards and regulatory requirements by providing technical analysis to support impact assessments and investigationsBuild strong relationships with stakeholder groups to create a culture of high performance