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