LES ERIC JOHNSON

SUMMARY:

Over 30 years of operations, regulatory, Quality Systems, Chemistry, Manufacturing & Controls (CMC), quality control (QC) analytical, and manufacturing experience in industry. Expertise in a wide range of technologies, markets, and products in the areas of bio-pharmaceuticals, pharmaceuticals, vaccines, cellular therapies, cellular products and devices; developing and managing complex, worldwide regulatory, engineering, manufacturing, and operational projects; Contract Manufacturing Organization (CMO) contracting and management, including development, validation and commercial supply agreements; performing due diligence and assessing real product, project and site value for investors, acquisitions, mergers and for contracting purposes; assessing quality, manufacturing and operational systems and developing/managing effective business and regulatory strategies and optimization, development, and commercialization plans. Has provided expert advice to start-up and transitioning companies including well developed cost modeling, risk analysis programs, contract templates and building full quality systems.

WORK EXPERIENCE:

2012 – Present RRD International, LLC, Rockville, MD

Senior Technical Advisor Performs a highly experienced advisory role in RRD's partner programs. This may involve business development activities related to RRD direct partnerships with pharma and biopharma companies. Takes a leadership role on RRD projects providing project management, drug development, process development, financial, regulatory, CMC, and quality expertise to Partner companies and joint development teams. Provides advice on strategic plans and GMP projects. Head of Quality for ClearPath Vaccines Corporation, a subsidiary of RRD. Leads efforts to discover, assess and assist the development of new products and technologies. Provides process and project financial modeling and risk analysis to allow the accurate calculation of the current and potential value of projects.

Built and maintained the Quality Management System for ClearPath and several partners. Takes lead role in the writing and submission of several documents to the FDA and other regulatory agencies, including INDs, NDAs, Annual Reports, White Papers and Audit Responses. Conducts qualification, pre-IND and Pre-NDA Audits of service and material providers. Leads teams to conduct scientific investigations, resolve deviation and develop proper corrective and preventive actions.

2008 – 2012 Salamandra LLC, Bethesda, MD

Senior Consultant – CMC and OperationsPosition as Interim Corporate Officer for Operations, Regulatory and Quality for a cellular vaccine sponsor. Involves manufacturing sites on 4 continents and suppliers from over 12 countries. Phase 3 studies being approved for start by

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TGA, EMA and FDA for over 1000 patients. Present scientific questions, attend various meeting and provide all amendments to these agencies. Help clients locate and qualify for funding through government and industry sources. Assess, write and submit CMC documentation to various agencies for clients as well as contributing to other portions of submissions. Assess, build and repair quality systems for several clients, including Unither Virology, US Army research facilities and several DOD/CDC/BARDA/JVAP contractors. Built quality system for Salamandra.

Work with leading cellular therapy companies to ensure their compliance, set their regulatory strategy and optimize their processes. Provide industrial expertise and best business practice guidance to clients in broad range of CMC, Financial, Operational, Quality and Developmental areas for biotechnology, cell therapy and medical device products. Provide specific guidance to several vaccine manufacturing clients, including BSL-3/GMP plant and laboratory design. Assess client quality, manufacturing and operational systems – providing gap, risk and cost analysis. Develop and execute optimization programs and fix GMP, GTP, GLP deficiencies.

Broker and manage supply agreements, contract manufacturing and contract testing services for clients. Provide due diligence services in support of acquisitions and mergers. Provide entire range of management and execution assistance for major quality, manufacturing and engineering projects. Lead business development efforts – significantly increasing client base and revenue. Create community outreach program including mentoring programs with UMD, UMUC and UMBC, and charity fund raising and food drives.

2007 – 2008 Celsis In Vitro Inc, Baltimore, MD (Formerly In Vitro Technologies)

Vice President of Product OperationsWorked directly with US, EU and Asian Sales/Marketing to set short and long term production goals, establish marketing strategies, customer satisfaction, supply agreements and new product opportunities. Established quality system and re-designed manufacturing operations to improve product quality, ensure delivery and optimize profitability. Set regulatory strategy and invited FDA to audit processes and to establish regulations for human tissue products industry. We were first and only company to establish GTP operations. Established working customer complaint and deviation/CAPA system to direct process and product improvements toward customer satisfaction.

Presented to potential merger partners. Developed and launched 2 new product lines. Managed all Product, QC Method and Process Development activities and tracked cost/benefit. Reported directly to CEO and CFO regarding: Division finances – established operating budget process, operational excellence tasks, installation of Quality Systems, process and product development program, and all strategic initiatives.

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Created Master Database from 8 years of processing data – used data to significantly improve productivity, strategic use of raw materials (human tissues) and profits. Increased profits 2-fold per year. Created databases to manage complex product formulations, product cost and pricing, QC Data and control inventory.

2006 - 2007 Cambrex Bio Science, Baltimore, MD (Now Lonza – Plant Closed)

Senior Director of Commercial Operations, Planning and LogisticsResponsible for all commercial aspects of operations on site: project management, client relations, customer service, sales management and support, Manufacturing and Quality Control Testing schedules and reporting, regulatory planning and consulting services to clients, materials management and supply chain, resource management – R&D, QC, QA and Production, site planning and safety, validation projects – Internal and under contract, all contract development, negotiation and closing, and all logistics for unit.

Worked directly with General Manager and other corporate officers to maximize potential sales value of Cambrex (Bio Division) and was on team to present and negotiate with all bidders. Then worked on transition team with Lonza after their purchase of Cambrex.

2004 – 2005 Progenitor Cell Therapy – Hackensack, NJ and Mountain View, CA

Senior Director of Manufacturing and OperationsBrought Manufacturing and Quality Control Operations for cellular therapies into GTP compliance. Hosted first FDA inspection of cellular products manufacturer and trained field inspectors. Established QC as stand-alone profit center doing internal and contract testing. Managed Client Relationships and Developed Contracts – doubling number of clients under contract and delivering products for 8 clinical trials. Lead Consultant to several clients moving into clinical or commercial phases, including setting regulatory strategies and writing submissions. Managed all QC method, process and facility validations. Designed and developed new facilities for both East Coast and West Coast operations.

2002 – 2004 Biosynexus Incorporated, Gaithersburg, MD

Vice President – Technical OperationsBrought two products (antibiotic and vaccine) up to Phase 2 clinicals and set manufacturing, quality and regulatory strategy through commercial phase. Developed and directed staff in the areas of Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, Validation (process and QC methods), Process Development and Project Management. Designed and operated aseptic filling systems for semi-solid product formulations. Supervised and audited contract fill/finish operations for vaccine product. Oversaw all regulatory submissions (INDs, BLAs, supplements and amendments) related to CMC and testing. Hosted agency audits resulting in no citations and prepared for pre-approval inspections. Negotiated sale of these products to major biopharmaceutical companies.

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2001 – 2002 Biologics Consulting Group LLC

Senior Consultant, Process and OperationsProvided quality (QA and QC), technical and operational consulting services to clients. Major project was with GATES Foundation to establish international development and manufacturing consortium for a MenA vaccine; Validation master plans, QC data analysis and reporting, design and implementation of quality systems programs – testing effectiveness, regulatory strategy (US, EU and Indian), GLP/GMP audits – more than 20 Due Diligence for merger-acquisitions and investors, international project management – CMO/CRO contracting, and Aseptic Processing and Barrier System design and testing. Wrote and presented courses on Process Validation, QSIT/PAT and upcoming FDA quality initiatives.

2000 – 2001 Baxter Hyland Immuno Corporation (former NAVA), Columbia, MD

Plant Manager and Director of ManufacturingPlant Managers position reporting to CSO of Immuno Corporation, then to VP of Baxter International Production. Direct responsibility for all Vaccine (MenC and Pertusis) Manufacturing, Engineering, Regulatory (CMC and Quality), Quality, Facilities, Housekeeping, Environmental Health and Safety, Production Planning and Maintenance – 8 departments with approximately 200 people. Took over plant with record number of 483 citations and warning letters – negotiated with agency, set and executed action plan, resolved all deviations, made process changes and brought plant back on line in 6 months at full capacity. Was site lead and main interface during restructuring after acquisition by Baxter.

Led regulatory team to have plant re-inspected, re-licensed and products approved for commercial sale. Brought entirely new quality systems approach to site – worked with Baxter corporate quality leaders to meet standards and qualify for annual quality award. Assisted Baxter Corporate Acquisitions team with the assessment of several potential companies and did full due diligence and helped with negotiating three acquisitions by Baxter. Member of corporate committees including Baxter Quality Awards Council (Malcolm Baldridge), Manufacturing Quality Council, Global Readiness Committee, SITE Council, etc.

1997 – 2000 Protein Polymer Technologies, Inc., San Diego, CA

Director of BioprocessingSenior staff position with leading edge company specializing in the design, development and application of silk-elastin block co-polymer materials for use as tissue replacements, medical adhesives and drug delivery. Established Quality Systems on site and implemented employee training program. Responsible for design and build-out and FDA inspection of manufacturing facility. Submitted pre-IDE, IDE, IDE supplements and amendments for FDA approval.

1993 – 1997 Bayer Pharmaceuticals, Biotechnology Division, Berkeley, CA

Senior Process Development Scientist/Engineer

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Led Quality Review team to study process statistics, resolve deviations, determine process changes and optimize employee training in areas of bioprocessing and aseptic fill/finish. Quality representative to engineering team - conducted HAZOP, DDA and COG studies for site. Bayer Quality Improvement Award for 1997. Transferred Quality Systems and inspection experience to 2 other Bayer sites – preventing numerous inspection citations and improvement of quality across company’s bio-divisions. Led CMC teams for ELA, INDA, NDA and PLA for site. Planned and executed installation and validation work on $160MM production facility. Plant Engineer for the development facility - responsible for over $14M of architectural changes.

1987 – 1993 Berlex Biosciences (formally Codon, Division of Schering A.G.), Richmond, CA

Manager of Purification SystemsManaged group responsible for all downstream process development and pre-clinical manufacturing of human and animal therapeutics, including aseptic filling. Established GLP testing lab for product release. Designed and operated USDA facility for the production of recombinant fractional vaccines for veterinary use. Member of several patent, ELA and PLA teams (ß-interferon).

1982 – 1987 Cetus Corporation (now Chiron), Emeryville, CA

Production SupervisorSupervised all GMP production, formulation and aseptic filling in Biotech's first licensed facility. Designed and installed all process equipment including automated fill/finish line. Developed in-process assays and transferred them to quality (HPLC, SDS PAGE, etc.). Hosted first FDA inspections for recombinant biologics.

EDUCATION:

1981 BS, Chemistry, Hayward State University, Hayward, CA

1977 - 1978 Oceanography Major, Long Beach State University, Long Beach, CA

OTHER EDUCATIONAL EXPERIENCE:

Continued Education through University of California Extension and MIT BiochemicalEngineering (etc.)

PROFESSIONAL AFFILIATIONS:

International Society for Pharmaceutical Engineering (ISPE)Maryland Tech CouncilIndia Biotechnology Chamber of Commerce

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Who’s Who – Biotechnology

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