PK Yegneswaran, PhD

Offering consulting and advisory solutions in the areas of biotechnology, pharmaceutical process development, technology transfer, commercialization strategies, life cycle management, due diligence, external partnerships, digital transformation, knowledge management, leadership development, mentoring and coaching. Scope includes Pharma/Biopharma/Biotech/Global Health Foundations/Private Equity/Early Stage/Venture Capital firms including fractional CXO solutions, Contributions include working with biopharma, biotech and global health organizations such as the Gates Foundation and the Children's Investment Fund Foundation to enable commercialization and supply of novel therapeutics and vaccines using innovative approaches to solve global health challenges.

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Led the Manufacturing Science and Technology (S&T) for Global AH Manufacturing at Merck, including commercialization of new products and technology aspects of product life cycle management across pharmaceuticals, vaccines, biologics and devices at over 25 internal and over 100 CDMO sites to ensure compliant, reliable and competitive supply of 100s of products. Selected Highlights Led the commercialization and technical aspects of launch of ~ 8 new products / year across vaccines, biologics and pharmaceuticals. Sponsored Merck's Innovation Community of Practice to create an ecosystem where innovation is nurtured and moved rapidly from ideation to implementation resulting in 100s of ideas moving through the "innovation hopper" Developed and initiated execution of a multi-year technology roadmap to enable new product realization and COGs improvements of over $500million for small and large molecules including continuous manufacturing, RNA particle technology platform, novel dosage forms such as sphereons, process analytical technologies and data science and analytics. Executed due diligences for for >25 potential Mergers & Acquisitions with subsequent integration of technology groups across organizations for completed M&As Sponsored the the Asia Pacific Association Employee Business Resource Group. Represented Merck & Co., Inc. on the Board of Directors of NACME (National Action Committee for Minority Engineers).

Led the manfuacturing technology support of global pharmaceutical manufacturing including API, formulation, devices and packaging for Merck at over 15 internal sites and over 75 external partners across Americas, Europe and Asia Pacific regions including in emerging markets supporting revenue of over $35B and ensuring compliant, reliable, competitive supply. Technologies include API, Solid Dosage, Sterile, Devices and Packaging. Selected Highlights Successfully completed over 100 technology transfers and regulatory filings to execute on Merck's supply network consolidation strategy and localizations to enable access to Merck's products in Emerging Markets. For a period of 12 months also led the Global Pharmaceutical Commercialization organization for the commercialiation of over 10 new pharmaceutical products and devices from phase 2 through launch and transition to supply at internal and external sites. Led a refresh of Merck's Sterile Products Supply Strategy resulting in key decisions enabling the reliable, cost competitive supply of our sterile products globally.

Leadership of pharmaceutical manufacturing technology groups in EMEA and Asia Pacific regions for Merck & Co., Inc. Responsibility for enabling compliant supply and continuous improvement of in-line products and introduction of new products and development of technical talent at over 50 internal sites, and local partners in the EMEA and AP regions. Selected Highlights Led the integration and development of technical operations groups from legacy Schering Plough into Merck with a 4X increase in scope of responsibilities. Resolved over 100 issues to ensure compliant, reliable supply across the internal and external network through problem solving and support of regulatory inspections. Initiated and executed over 50 technology transfers related to the divesture of Merck Consumer Care to Bayer Improved Cost Of Goods by over $500million through application of lean six sigma, operational excellence and productivity improvements. Introduced over 5 new products at internal and external sites through efficient technology transfers

Led the Technical Operations groups at ~ 8 global sites to provide technical support to API, Pharmaceutical, biological, sterile and packaging operations ensuring compliant and reliable supply and enhancing productivity. As a member of the EMEA Manufacturing Leadership Team contributed to running the business in the EMEA with specific leadership in the areas of Portfolio Management, Lean Six Sigma, PGM Enhancement, Emerging Markets support, Anti-counterfeiting, Talent Management and Organizational effectiveness.

Led a group of scientists and engineers for process development and commercialization of all of Merck's growing portfolio of sterile products (vaccines, therapeutic proteins, sterile pharmaceuticals) for formulation / filling steps for Phase I/II through Launch and post-launch optimization at internal Merck and External Partner sites. Championed development and realization of platform process technologies and business processes (technologies and business processes) to efficiently enable a growing pipeline of sterile products with focus on customer value.

Led and developed a group of approximately 55 scientists and engineers to provide technical support for bacterial vaccines and validation support for all of Merck’s vaccines and sterile pharmaceuticals (over 15 products across multiple sites). Validation activities included strategy development, execution, filing, FDA interactions for process , cleaning, sterilization, filtration and container closure validations.

Various technical and program leadership roles in the areas of fermentation and vaccine process development, commercialization, manufacturing and supply for over 10 products. Led A ~$100M capital project for vaccine manufacturing including technology transfer and commercialization.