Anthony Toscano Email and Phone Number

Biopharmaceutical Supply Chain

1) Manage end to end supply chain activities for the R&D pipeline including new product launch, supply and demand planning , rough cut capacity planning, and raw material, drug product, and finished goods planning.2) Aggregate clinical demand across the R&D pipeline from pre-clinical to life cycle management. Interpret and operationalize demand into short term and long term manufacturing schedules.3) Accountable for maintaining and managing the clinical Master Production Schedule (MPS). Ensure timely delivery and release of drug product manufactured internally and externally. 4) Collaborate regularly with Operations to determine resource load and capacity utilization. Manage the Book of Work (BOW) for Oral Solid Manufacturing and Parenteral Manufacturing. Continuously evaluate production capacity to ensure balance of workload across internal and external manufacturing.5) Work closely with Procurement and Materials Management in Material Requirements Planning (MRP) and Inventory Management. Ensure all raw materials are ordered, delivered and released on time to support both insourced and outsourced drug product manufacture. 6) Effectively manage cross functional supply activities focusing specifically on alignment across Global Quality Regulatory Compliance, Analaytical-Bioanalytical Development, Materials Management, and Operations to ensure on time release and delivery of finished clinical supplies.7) Designed and implemented database tools to better manage Materials Planning and Demand Aggregation.8) Identify and manage drivers of key performance metrics in order to meet organization targets and to identify processes which required continuous improvement.9) Drive and manage a Demand and Operations Planning Process for Senior Leadership. This results in consensus on strategy for critical projects, addresses supply issues and major changes, and builds alignment across functional areas.

• Evaluated third party suppliers for manufacture of Active Pharmaceutical Ingredients (API). Performed audits to evaluate potential suppliers for technical fit, production capacity, cGMP compliance, and total landed costs.• Successfully transferred an API chemical synthesis process to a third-party supplier. The change in supplier reduced cost of production, simplified the supply chain, and created process improvements resulting in improved production yield by 20%.• Gained experienced in managing projects related to new product launch. Experience included justifying business decisions, evaluating product and production documentation, market analysis, developing a supply chain, evaluating cost of goods, determining total landed costs, performing supplier due diligence, and identifying regulatory requirements.• Collaborated with global external suppliers. Worked closely with and visited third party manufacturers in China, Brazil, Canada, Japan, Mexico, and US.• Successfully implemented process improvement programs at third party suppliers in large-scale antibiotic fermentation and chemical synthesis processes. This led to improved production titers.• Provide third-party suppliers with technical support. Facilitated project team meetings which successfully resolved problems and determined plan forward.• Responsible for drug master file annual updates.• Knowledgeable in the science and management of large-scale API production including fermentation, purification, chemical modification, and formulation.

• Managed projects in mammalian cell line optimization, pilot scale process development, and development and implementation of cGMP processes for large-scale monoclonal antibody production.• Experienced in managing projects for the design and construction of a Biopharmaceutical production facility and the design and installation of Biopharmaceutical production equipment.• Planned, directed, and coordinated daily activities in the process development and manufacturing suites. Managed a group of four employees consisting of two chemical engineers and two biologists.• Successfully developed and implemented large-scale monoclonal antibody production processes using technologies in hollow fiber perfusion systems, Wave™ bioreactor systems, and stirred tank bioreactor systems (batch and fed-batch).• Wrote, maintained, and reviewed documents such as standard operating procedures, product specifications, master batch records, validation reports, department monthly reports, and process development reports.• Started-up a pilot scale process development laboratory for the evaluation of mammalian cell culture processes.• Successfully optimized cell culture processes which increased cell culture density, improved cell culture viability, and increased product titers.• Completed an Installation Qualification, Operational Qualification, and Process Qualification for the validation of Biopharmaceutical production equipment i.e. stirred-tank bioreactor, clean-in-place skid, and large-scale filtration skid.• Experienced in validating and implementing 21 CFR Part 11 compliant computer systems.• Developed, implemented, and validated cleaning processes for multi-product Biopharmaceutical equipment, such as, large-scale mixing vessels, filtration skids, and stirred-tank bioreactors. • Earned two promotions within five years. Research Scientist--Senior Specialist--Manager.

Research Scientist, Roche Vitamins, Nutley, NJ • Operated and maintained stirred-tank bioreactor systems and computer control systems. The working volumes of the stirred-tank bioreactors ranged from 3 liters to 100 liters. Successfully executed over 250 stirred-tank bioreactor runs.• Optimized fermentation processes by improving stirred-tank bioreactor design, medium composition, and nutrient feeding strategies. The optimization studies resulted in increased riboflavin production via Bacillus subtilis by 13%.• Studied the biochemical pathways of B. subtilis via stirred-tank continuous culture fermentations. This included evaluating genetically engineered strains with introduced auxotrophy, gene dosage, increased levels of pathway precursors, and modifications in central metabolism.• Organized and supervised processes in the fermentation group.Manufacturing Scientist, Roche Vitamins, Belvidere, NJ • Gained experience in the science and management of large-scale antibiotic production.• Managed projects which successfully optimized sterile processes in large-scale antibiotic production. Designed and implemented new air filtration systems, exhaust systems, sampling systems, and cleaning procedures.• Wrote and maintained documents which focused on improving sterile design for large-scale stirred tank bioreactors. (7500L Vw and 100,000L Vw)• Authored and maintained investigational reports which were used in identifying contamination issues and then subsequently diagnosed causes and determining corrective actions. The data generated from the investigation reports resulted in successfully reducing contamination to levels better than industry standards.• Communicated progress to the management team and corporate QA by written reports and quarterly presentations.