Dipak Goyal
Technical Project Leader | Sterile Injectables & BFS | High-Velocity Execution from Development to Commercialization | Cross-Functional Delivery
- Role
- Sr Manager, Technical Pmo at Aveva Drug Delivery Systems
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Dipak Goyal
Senior technical project management professional with deep expertise in sterile injectables, BFS manufacturing, and complex generics. Driving programs from early development through scale-up, Exhibit Batches, and commercialization. Skilled in navigating technical, operational, and regulatory complexity while advancing high-priority programs under aggressive timelines.Expert in sterile injectables, inhalation, ophthalmic, and complex liquid formulations. Adept at leading cross-functional teams—R&D, QA, QC, Manufacturing, Supply Chain, and CDMOs—to deliver technically sound, compliant, and execution-ready outcomes.Recognized for converting scientific and operational constraints into clear, actionable project strategies. Experienced in resolving analytical and method-transfer challenges, strengthening media fill and sterility readiness, optimizing sampling and stability plans, and driving CAPA and deviation closure with urgency and discipline.Core Competencies• Sterile injectables & BFS scale-up• Complex generics & ANDA program execution• Tech transfer (R&D → Manufacturing)• Cross-functional leadership and stakeholder alignment• Regulatory readiness, risk management & compliance• Vendor, CMO, and analytical lab oversight• Portfolio planning and technical program governance• Stability strategy & scientific communication
Experience
Sr Manager, Technical Pmo
Jul 2025 — Present · Miami-Fort Lauderdale, FL, US
Led sterile and BFS programs across development, Exhibit batches, scale-up.• Built cross-functional execution frameworks ensuring analytical, operational, and regulatory readiness.• Strengthened media fill strategy, sterility assurance, and validation approaches across BFS lines.• Directed outsourcing, CMO partnerships, and analytical lab coordination to maintain project velocity.• Resolved method-transfer challenges, compliance gaps, and stability strategy issues with urgency and clarity.• Supported regulatory submissions through technical report generation, risk assessments, and documentation alignment.
Education
University of Massachusetts Lowell
Master of Science
University Department of Pharmaceutical Sciences, Nagpur University
Bachelor’s Degree
University of Massachusetts Lowell
PhD
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