Prakaash R

About Prakaash R

Experienced Operations, Engineering, and Capital Projects leader with a strong track record in GMP manufacturing start‑ups, scale‑ups, and operational readiness across OSD, Sterile, and Biologics environments. I am passionate about building advanced manufacturing facilities and transitioning them into stable, high‑performing operations that meet the highest standards of quality, safety, and compliance.Over my career, I have led end‑to‑end delivery of greenfield and brownfield manufacturing programs, from early project definition through commissioning, qualification, and integration into routine GMP operations. My experience spans engineering execution, manufacturing enablement, cost optimization, and enterprise‑level operational governance, with a strong focus on Europe‑style regulatory rigor and inspection readiness.Key Areas of Leadership & ImpactManufacturing & Operations LeadershipProven leadership in technical operations for OSD, sterile, and biologics manufacturing, driving reliable, compliant, and efficient operations aligned with global supply‑chain needs.Capital Projects & Site Start‑UpExtensive experience leading large capital projects, including greenfield site development and brownfield expansions, with a clear focus on start‑up, scale‑up, and smooth handover to operations.Engineering Strategy & ExecutionStrong capability in shaping engineering strategies that support advanced manufacturing concepts, automation, paperless systems, and standardized design approaches to enable long‑term operational excellence.Financial Stewardship (AOP & CAPEX)Demonstrated ownership of AOP planning and CAPEX governance, ensuring disciplined investment decisions, cost control, and value realization across complex project portfolios.Quality, Compliance & Risk ManagementDeep commitment to cGMP compliance, quality systems, and risk‑based decision‑making, ensuring facilities and operations are inspection‑ready from Day One.Manufacturing Science & Technology (MS & T)Hands‑on leadership in technology transfer, process readiness, and operational integration, enabling seamless knowledge transfer across sites and regions.Enterprise Programs & StandardizationExperience developing corporate roadmaps focused on standardization, OPEX, audit readiness, and manufacturing maturity, supporting consistent execution across global networks.People Leadership & CultureRecognized for building and mentoring high‑performing, cross‑functional teams, fostering a culture of ownership, continuous improvement, and collaboration across geographies.

Experience

1. Director - Engineering Center of Excellence, Sterile & Osd Formulations

   Teva Pharmaceuticals

   Apr 2025 — Present

Education

• Shillong College

  Master's degree, Pharmaceutical Process Engineering

• All India Institute of Medical Sciences

  Diploma in TQM & ISO 9000, Quality Management

• National College - Mumbai

  Master's Degree, Pharmaceutics

Skills

• Regulatory Requirements
• Gmp
• Glp
• Product Development
• Technology Transfer
• Oncology
• Validation
• Pharmaceutical Industry
• Sop
• Fda
• Pharmaceutics
• Quality System
• Process Simulation
• Formulation
• Regulatory Affairs
• Generic Programming
• Manufacturing