Dipak Sakharkar
Global Biotech & Pharma Transformation Leader | Digital Manufacturing, AI/ML & Analytics | Biotherapeutics Engineering, MSAT & Process Lifecycle Excellence | Industry 4.0/5.0 | Cloud, Cybersecurity & Emerging Tech
- Role
- Program Manager - Digital, Technology, & Innovation (Dti) at Amgen
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Dipak Sakharkar
Global biopharma executive driving digital transformation, industrial AI, and smart manufacturing (Industry 4.0/5.0) across the full product lifecycle. I transform clinical development, R&D, manufacturing, and commercial operations into AI-powered, sustainable engines of growth, improving outcomes for 30M+ patients worldwide.As a trusted advisor to C-Suite leaders and regulators, I bridge the gap between deep technical innovation and top-level business strategy. My expertise lies in aligning digital roadmaps with capital allocation, regulatory compliance, and ESG goals to de-risk transformation and maximize shareholder value.Measurable enterprise value delivered:$500M+ in new revenue and $100M+ in cost savings30–40% efficiency gains and 18% CO₂ reductionInfluenced $2B+ in board-level capital allocationSustained zero audit findings across 10+ global cGMP sitesRecognized for pioneering industry-first platforms — including the first cleared federated AI under GMP, blockchain serialization reducing diversion risk by 90%, and digital twins generating $20M+/year in savings — while building future-ready ecosystems that integrate AI, robotics, and digital quality systems to strengthen supply chains and improve patient safety.Passionate about mentoring the next generation of leaders and advancing the future of biopharma through AI-first, sustainable operations and robust ESG accountability.Core CompetenciesStrategic Leadership & Governance | Capital Allocation | P&L Strategy | Board & Investor Engagement | M&A Integration | DEI & Succession PlanningAI, Data & Analytics | Generative & Agentic AI | Federated & Explainable AI (XAI)| Digital Twins | MLOps | Data Governance | Precision MedicineDigital Platforms & Automation | MES–ERP–LIMS–DCS/PLC/SCADA | IIoT/AIoT | Robotics & Edge AI | Computer Vision | Cloud/DevOpsQuality & Regulatory Excellence | GxP Compliance | CSA Validation | Aseptic Fill-Finish | Tech Transfer | ICH Q12/Q13Cybersecurity & Resilience | OT/IT Zero Trust | IEC 62443 | Quantum-Resilience | Business ContinuitySustainability & ESG | Carbon-Aware Operations | ESG Reporting (CSRD/SBTi/SEC)| AI-Driven Climate Risk | Circular EconomyOpen to connecting with leaders, innovators, and investors advancing the future of biopharma.
Experience
Program Manager - Digital, Technology, & Innovation (Dti)
Dec 2024 — Present · US
Education
Dartmouth College
Master of Engineering - MEng, Computer Engineering (AI & Intelligent Systems)
COEP Technological University
Bachelor of Engineering, Instrumentation & Control (Electrical Engineering) with specialization in Biomedical Engineering.
Thayer School of Engineering at Dartmouth
Master of Engineering, Computer Engineering
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