Sree Vadlamudi

me@SreeVadlamudi.com

Senior pharmaceutical manufacturing executive with 30 years of experience building sterile and non-sterile operations from the ground up - now advising companies on facility design, regulatory readiness, and operational execution that bridges boardroom vision with shop-floor results.

Executive Profile

  • I specialize in building capability where none exists and driving performance where it matters most.
  • My work spans Rx, OTC, Medical Devices, Compounding Pharmacies, Animal Health, Supplements and Cosmetics.
  • Direct experience handling API’s and products in the following categories – hormones (male and female), high potency, cytotoxic, immunosuppressants, flammables, biologic and DEA controlled.
  • Possess the breadth of expertise needed to support solid dosages (tablets, capsules and gelatin enrobed dosages), powders, liquids, suspensions, creams and ointments, suppositories, nasal sprays, transdermal patches, ophthalmic drops (unit doses, preserved and preservative free), and towelettes.
  • My most recent projects involve sterile drug manufacturing facility design, validation, technical services, and regulatory strategy - all delivered through disciplined execution and deeply engaged leadership.
  • Skilled at turning complex regulatory and technical challenges into competitive advantages, from greenfield facility development to post-acquisition integration.
  • Built organizations that scale, systems that sustain, and products that succeed, all under the scrutiny of global regulatory bodies and commercial realities.
  • A builder and fixer by nature, I excel at transforming underperforming teams and legacy operations into best-in-class manufacturing assets.
  • Adept at aligning corporate strategy with regulatory, technical, and operational execution across drug, device, and cosmetic categories.
  • Recognized for disciplined execution, cross-functional leadership, and building long-term enterprise value.

Core Competencies

  • GMP Facility Design, Build and Startup
  • Pharmaceutical Operations Leadership (Rx, OTC, 503(a) and 503(b), Device, Cosmetics)
  • Sterile Manufacturing (Aseptic, Terminal Sterilization, Ophthalmic)
  • End-to-End Facility Development (Concept to Commercialization)
  • Regulatory Excellence (FDA, MHRA, EU, ISO, ICH Q8/Q9/Q10)
  • Organizational Transformation, M&A Integration
  • Supply Chain Optimization, CDMO Expansion
  • Board & CxO-Level Reporting, P&L Ownership
  • Lean, Six Sigma & Digital Manufacturing