Anatoly Ustyanich

About Anatoly Ustyanich

HEADACHE LIQUIDATORResult oriented executive with 25 years of global experience in the pharmaceutical R&D and MFG, including various drug products formulations, solid dose, soft-gels, topicals and medical device products (Brand, Rx, OTC, Generics) from early-stage development, through Phase 3, Scale-Up, Tech-Transfers, New Product Launches, Commercial manufacturing and troubleshooting.Product Development | Technical Operations Successfully leveraged technical knowledge, business acumen and project management skills to enable timely product development and commercialization. Great in identifying and resolving complex tasks and translating complex projects into easy to understand and follow milestones. Innovative strategic thinker, visionary and prudent risk-taker. Developed, optimized and troubleshooted over 100 products. Managed project portfolios up to 80 products, budgets up to 20MM. Built and led teams up to 40 professional, operated up to 4 sites. ACHIEVEMENTS HIGHLIGHTS - Designed successful business strategies to overcome revenue losses- Salvaged 6 products (Oxycodone family) from withdrawal off the market enabling continues revenues in excess of 90MM- Troubleshooted Vitamin C continuous manufacturing process enabling additional revenues of $15MM- Developed process “What-if” analysis tool, which significantly reduced the number of development trials, lead times by 6-12 months and cost of development in excess of 2MM per product- Optimized an array of modified release products that resulted in annual cost savings of ~ 2MM per product- Reorganized R&D staff into unified, top-performing, highly motivated teams. CORE COMPETENCIES- Formulation & Process Development - New product Launch & Commercialization - MFG Troubleshooting - Continuous improvement - Data analysis & interpretation - Risk assessment & mitigation - Technical documentation - Authoring CMC, CTD, IND and ANDAs - Regulatory guidelines interpretation: FDA, TPD, EMEA, cGMP - Business processes optimization - KPIs establishing & monitoring - Staff mentoring & motivation - CROs/CDMOs Liaison Currently interested in leadership opportunities in product development, commercialization, tech-transfer, TechOps, validation and program management.

Experience

1. Associate Director, Osd Technical Transfer

   Alexion Pharmaceuticals, Inc.

   Jun 2023 — Present · New Haven, CT, US

Education

• Lviv Polytechnic National University

  M.Sc. Honor, Chemical Engineering

• Rensselaer Polytechnic Institute

  Certificate, Technological Entrepreneurship and Economic Development

• Ryerson University

  Certificate, Business Communication

• National Technical University "Kharkiv Polytechnic Institute"

  Ph.D., Industrial Pharmaceutics

Skills

• Manufacturing
• Biopharmaceuticals
• Organizational Development
• Computer System Validation
• Business Strategy
• Validation
• 21 Cfr Part 11
• Budgets
• Regulatory Affairs
• Product Development
• Technology Transfer
• Process Optimization
• R&D
• Root Cause Analysis
• Medical Devices
• Capa
• Biotechnology
• Process Engineering
• Business Analysis
• Pharmaceutics
• Commercialization
• Training
• Gxp
• Continuous Improvement
• Quality Control
• Management
• Gmp
• Cross-Functional Team Leadership
• Process Improvement
• Operational Excellence
• Leadership
• Change Management
• Quality System
• V&V
• Quality Assurance
• Process Simulation
• Pharmaceutical Industry
• Business Process Improvement
• Sop
• Fda