Robert Litwin Email & Phone Number

Berkeley, Ca

Directed Engineering, Maintenance, Instrumentation & Calibration, Environmental Health and Safety, Security, janitorial services, and real estate transactions, serving a campus of eight buildings which include manufacturing, pilot operations, warehousing, R&D, and Quality Control Labs. Interfaced with all levels to ensure that corporate and operational plans and requirements were achieved to support all manufacturing activities. Restructured all groups, upgraded equipment, systems, documentation, and facilities to modernize and improve operations to move the organization towards a state of full GMP production capability.AccomplishmentsGained FDA agreement on a new manufacturing facility and utility design.Reduced Workers Compensation Experience Modification Ratio (EMR) and Workers Compensation Insurance costs by 45%.Successfully decommissioned, decontaminated and closed three facilities encompassing QC Labs, manufacturing and utilities to the acceptance of governing agencies and the City of Berkeley; including the decommissioning and removal of a 2,000 gallon Underground Storage Tank, termination of Radioactive License, and removal and liquidation of building related assets.

Thousand Oaks, Ca

Successfully directed the design, construction, validation, regulatory approval, and start up of biotech manufacturing facilities.Responsible for a $70mm simultaneous expansion project, including all aspects of additional site development, expansion of manufacturing capacity (Cell Culture and Purification), new 45,000 sq. ft. Quality Control Laboratory and office building, and tenant improvements to 80,000 sq. ft. off site warehouse with H3/H7 occupancy storage.Also, for all facets of an $80mm expansion of mammalian cell culture and purification operations to triple the production capacity of recombinant Factor VIII. This included all project and design functions associated with a 60,000 sq. ft. manufacturing space, all utilities, expansion of 10,000 sq. ft. on site warehouse, Quality Control Laboratory, and office space, consistent with cGMP’s and European regulatory requirements.Accomplishments• Provided project direction and management leading to completion at 7% and 25% under budget, on and ahead of schedule.• Performed cost segregation resulting in $16mm additional tax refund.• Completed 275,000 sq. ft. of build out under roof and led startup, validation, and licensing of projects.

Thousand Oaks, Ca

Directed all aspects of a manufacturing facility for Cell Culture Production, Purification, Aseptic Filling, Drying, and Packaging of Recombinant Factor VIII. In this position, had matrix responsibility over Quality Assurance, Quality Control and Regulatory Affairs, and direct responsibility for Manufacturing, Human Resources, Maintenance, Engineering, Technical Services, Metrology, Environmental/Health & Safety, Logistics, Purchasing, and Security. Accomplishments• Provided leadership resulting in FDA and EU licensure of Baxter’s first biotech manufacturing facility. • Increased staffing from 16 to 360 FTE.• Sales increase from zero to approximately one half billion dollars per year.

Los Angeles, Ca

Directed all capital within the Hyland Division (5 facilities), Project Engineering, Process Engineering, Facilities Engineering, Engineering Planning, Maintenance, and Control Systems, with simultaneous responsibility for design & construction of a 104,000 sq. ft. new biotech manufacturing facility. Directed a department of 112 FTE.Accomplishments• Division annual capital budget $45 mm and department expense budget at $18.5 mm• Instituted finished goods packaging changes resulting in savings of $1 million and Corporate Environmental Packaging Award.• Northeast Governors Award for waste reduction.