Akash Rathod

About Akash Rathod

I am an experienced pharmaceutical professional with over 11 years of expertise spanning formulation development, laboratory research, and strategic external partner management. My career began as a core scientist, working on New Chemical Entities (NCEs), generics, and OTC products across diverse dosage forms and life cycles. Over time, I advanced into leadership roles, including Formulation Project Lead, where I drove projects from Drug Substance (DS) characterization to Drug Product (DP) development, scaling up to GMP clinical supply while ensuring scientific rigor and regulatory compliance.Today, as a Senior Expert in External Partner Management (EPM/EBO), I lead end-to-end CMO portfolio delivery, foster strategic partnerships, and integrate scientific, business, and digital strategies to achieve global success. My work bridges science and business, enabling me to leverage technical depth for strategic outcomes. I thrive in dynamic environments where collaboration, technology, and data transform pharmaceutical development for better patient outcomes.Key HighlightsLeadership in External Partner Management: Driving DS→DP delivery with global CMOs, governance frameworks, KPIs, and risk management.Strategic Partnerships: Building and sustaining collaborations across USA, Europe, and ROW for global projects.Formulation Expertise: Led development for oral, nasal, NCE, and generic formulations; supported GL submissions.Global Exposure: Scientific assignment at Novartis Basel, Switzerland (2019) to embed global best practices.Digital Transformation: Spearheaded lab digitalization program; implemented Power BI dashboards and eLN templates.Data & AI Integration: Leveraging AI/ML tools for structured workflows, analytics, and decision-making.Continuous Improvement: Delivered Continuous Improvement project with annual savings through process harmonization and Lean Six Sigma initiatives.Regulatory & GMP Compliance: Authored CSF/FMI/MI; managed deviations and change control for inspection readiness.Cross-functional Leadership: Collaborated with global teams and CMOs to align scientific and business objectives.Innovation & Operational Excellence: Passionate about integrating technology and science to accelerate development.

Experience

1. Senior Expert, External Partner Management

   Novartis

   Dec 2023 — Present · Hyderabad, IN

   As the External Partner Management Lead at Novartis, I drive end-to-end project lifecycles for global pharmaceutical portfolios. Leveraging a decade of formulation development expertise, I integrate scientific depth with strategic business objectives to ensure successful externalization. My responsibilities include developing and executing externalization strategies, optimizing resources, and maintaining compliance with regulatory standards and industry best practices. I lead governance frameworks, manage KPIs, and foster strong partnerships with CMOs worldwide to deliver projects on time, within budget, and at the highest quality standards.what I deliver every day:Strategic Partner Management: I manage global external networks, negotiate agreements, and ensure compliance through robust governance frameworks.Operational Excellence: Proven track record of delivering complex DS→DP projects on time and within budget, while mitigating risks.Digital & Data Savvy: I implement dashboards, analytics, and digital tools (Power BI, eLN) to enhance transparency and decision-making.Regulatory Knowledge: Deep understanding of GMP, quality systems, and global regulatory frameworks; ensure audit readiness and inspection success.Leadership & Influence: I lead cross-functional teams across geographies, drive collaboration, and manage stakeholders globally.Cost Optimization & CI: Delivered substantial annual savings through Lean Six Sigma initiatives and process harmonization strategies.

Education

• Bharati Vidyapeeth

  Master of pharmacy (Pharmaceutics), Pharmaceutical Sciences

  2011 — 2013

• Bharati Vidyapeeth

  Bachelor of Pharmacy - B Pharm, Pharmacy

  2007 — 2011

• Yeshwant Mahavidyalaya, Nanded

  12th Science , Physics Chemistry and Biology

  2005 — 2007

Skills

• Quality by Design
• Regulatory Submissions
• Formulation Development
• Design of Experiments