Sankappa Rai Ph.D, PMP®

Seasoned Pharmaceutical professional with more than two decades of Industrial experience in Small molecule discovery, Process Development, Technology Transfer, CMC, HPAPI, CDMO, CMO, Program Management, ADCs, Outsourcing, RFP ,Vendor management
Techno-commercial individual with deep understanding of process development, Technology transfer and commercial manufacturing of NCEs and APIs.
Part of Syngene chemical development vertical responsible for Technical operation in the CRAMs… Show more

Seasoned Pharmaceutical professional with more than two decades of Industrial experience in Small molecule discovery, Process Development, Technology Transfer, CMC, HPAPI, CDMO, CMO, Program Management, ADCs, Outsourcing, RFP ,Vendor management
Techno-commercial individual with deep understanding of process development, Technology transfer and commercial manufacturing of NCEs and APIs.
Part of Syngene chemical development vertical responsible for Technical operation in the CRAMs business.
Expertise:
Technical operations:
Early phase candidate development and clinical supplies
CMC development and support regulatory filings.
Process development for the selected drug candidate
Process optimisation using QbD approach
Technology transfer and Technology adsorption
Commercial manufacturing and lifecycle management
Commercial:
Strategizing the pricing for new business opportunities
Branding and Advertising
Business strategies
Program management:
Customer engagement
Ontime delivery and troubleshooting
Delivery strategies
Manage finance and service metrics
Quality and Compliance:
Drive compliance across the organisation
Regulatory audits
Identification of CAPA and implementation Show less

Process development and scale up of pharmaceuticals, fine chemicals, GMP synthesis of APIs and advanced intermediates
Leading a team of over 40 team members to manage 20+ projects and responsible for meeting yearly business targets
Engaging clients to build strong alliances with global clientele in order to enhance current and new business opportunities
Analyzing KPIs of various projects and growth potential of clients’ development programs to enable strategic decision making at the… Show more

Process development and scale up of pharmaceuticals, fine chemicals, GMP synthesis of APIs and advanced intermediates
Leading a team of over 40 team members to manage 20+ projects and responsible for meeting yearly business targets
Engaging clients to build strong alliances with global clientele in order to enhance current and new business opportunities
Analyzing KPIs of various projects and growth potential of clients’ development programs to enable strategic decision making at the business unit level
Participating in conferences, client visits and audits to facilitate discussions on projects
Expanding the business collaborations with the existing clients and support BD to bring new business to Syngene
Identified suitable outsourcing partners based on infrastructure, equipment suitability, Quality systems, waste management systems and process safety in compliance to the norms
Implemented technical solutions based on process safety parameters and HAZOP analysis
Show less

Led a team of 25+ members to manage 15+ projects related to API development programs
Liaising with cross-functional teams for project planning, process evaluation, proposal and budget estimation
Responsible for technical reports and documents for technology transfer packages and troubleshooting during manufacturing processes
Responsible for end-to-end delivery of projects within the stipulated timelines.

Leading multiple drug development programs, coordinating with QA,QC,RA and formulation teams. Responsible for the delivery for investigational drugs of different therapeutic area for the various stages of clinical study, supporting IND enabling studies.

Leading the drug development team for supporting the development and manufacturing of investigational new drugs.