Shirish Patel

• Spearheading External Manufacturing Operations for Drug Products & Drug Substances, across Asia Pacific, with responsibility of BOI/P& L for 150M Euro Outsourcing Spend.
• Playing a key role in the identification, and negotiation with CMOs and facilitating scale-up optimization, and technology transfer of the product to CMOs, through cross-functional relationships to achieve defined goals
• Supporting M&A, and Divestment Activity from a manufacturing perspective. Working on Divestment Projects in India and other regions to ensure successful outcomes and value creation through Contract Negotiations for divestment
• Managing Supplier Relationships; enhancing performance on Supply Chain, Quality, HSE & Financial Aspects for 350 SKUs at peak; Driving Cost Benchmarking/ Capacity Mapping for the entire portfolio to identify key opportunities & best-in-class supply assurance with first-time-right quality
• Directing Large-Scale Process Improvement / Automation/ Cost Benchmarking, Supply Chain & CMO Optimization Projects from scoping, SOWs, resource planning, effort estimations, execution, progress tracking/ reporting to completion within defined time, quality, and budget norms
• Participating in Strategic Business Reviews/ Contract Negotiations with CMO Partners, with best terms & conditions
• Leading and monitoring the team’s performance, organizing training, and empowering people to deliver their best

• Front-led and managed end-to-end Quality, Supply, Regulatory, and Financial Performance for the Associated Contract Manufacturing Business Activity of 100 M Euro Spend, along with development & retention of key talent
• Played a key role in the Launch and In-licensing of multiple Products for Brazil Markets from the Indian CMO
• Served as a key part of the Industrial Leadership Team and CHC Leadership Team for Sanofi India
• Planned & executed various Outsourcing Projects involving Injectables, Tablets, Capsules, Soft Gel and Creams
• Front-led Business Reviews & Contract Negotiations with CMO Partner. Pioneered Contract Modernization, by penalties and several criteria
• Paved the way for CMO Rationalisation, Operational Excellence & Governance Mechanisms in the entire CMO Management Process
• Led efforts to achieve Optimization of Supplier Network from 44 to 12, fundamentals of industrial Activities (Supply, Quality, HSE, Cost)
• Facilitated Capex Investment at a key strategic CMO for optimization of Global Network for the supply of TB Products

• Facilitated decisions on the Site Divestment Process and readiness for divestment, integration of acquired business in India, and Curve-In and Curve-Out of Consumer and Animal Business
• Directed Strategic Projects for Industrial Affairs in India, Export Flows, New Product Planning, Cost Benchmarking, Site Capacity Rationalization, Spend Analysis, M&A Integration, Cost of Goods Improvement Projects, Lean Implementation at the Manufacturing Site, Site Divestment Decision, Project Management of Divestment and M&A along with CHC Business Curve Out, and Curve-In

• Successfully set up and managed a New Team for the Goa Manufacturing Site and a New Block with 3 Bn Tablet Capacity
• Monitored production schedules, and fostered lean ways of working on the shop floor for increased performance & productivity
• Facilitated the monitoring & achievement of all Site KPIs - Yields, Productivity (Control on Headcount) & Product Technical Complaints (PTC)
• Ensured the Plant Cycle Time (PCT) and Overall Equipment Efficiency (OEE) are attained as per the set targets
• Served as a Member of Site Leadership and Executive Committee, and contributed to long-range plans & capacity analysis, for the Goa site
• Worked on Strategic Projects/Capex at the site for production volume enhancements and people development
• Attained a Reduction in PCT for large-volume products by 70% through JIT implementation

• Led a team of Managers /Scientists for Analytical Research focusing on Generics /NDA /FDC Product Development for Global Markets
• Implemented a project-driven team structure to help maximize project outcomes and build focused scientific teams
• Oversaw sample management, KPI-driven reporting of sample analysis, structured method development & validation approach of methods
• Managed Stability Studies for Pilot Batches. Led the team for FDC Development & Registration from all analytical data perspectives
• Pivotal in setting up a New DC right from scratch, Digital Transformation of Laboratory via LIMS & Sample Management Tools
• Developed Automated Template for calculations of analytical data by OpenLAB software, automated Dissolution Studies for high-efficiency

• Strong method development skills demonstration and enhancing performance of self and team by really practicing the culture of the company, i.e. Dream big deliver big.
• Method development for a large number of projects in a very fast-track mode, and several of them are the first to file opportunities.
• Champion on polypill project for CVS.
• Motivated young scientists with detailed technical teaching to enhance technical aspects.
• Acted as key troubleshooter for various issues during product development in the generics division.
• Champion on impurity profile by HPLC/ UPLC and preparative isolation for new unknown impurities in finished product dosage form

• Worked for the method development of formulation products for the domestic markets as well as for South African and UK Markets.
• Provide analytical expertise to NDDS product development.
• Provided an active role in building their new Analytical development laboratory

• Worked for the method development of various drug intermediates and specialty chemicals.
• Online reaction monitoring of the process development samples by HPLC/GC
• Provide analytical support to organic synthesis research