Resumes
Les E. Johnson
Expertise
- Over twenty-five years industry experience in Manufacturing, Operations, Regulatory, CMC, Quality Systems, and QC Analytical encompassing: a wide range of technologies and products in the areas of bio-pharmaceuticals, vaccines, cellular therapies, cellular products and devices; assessing quality, manufacturing and operational systems and developing/managing effective optimization plans; developing and managing complex engineering, manufacturing and operational projects; CMO contracting and management, including development, validation and commercial supply agreements.
Professional Experience
| 2008 - Present | CMC and Operations Consultant Salamandra, LLC, Bethesda, MD |
- Preparing CMC documentation for regulatory submissions (INDs, NDAs, BLAs, DMFs)
- Providing industrial expertise and best business practice guidance in broad range of CMC, Operational and Developmental areas for biotechnology, cell therapy and medical device products.
- Assessing quality, manufacturing and operational systems, providing gap and risk analysis.
- Developing and executing optimization programs.
- Providing due diligence services in support of acquisitions and mergers.
- Providing entire range of management and execution assistance for major quality, manufacturing and engineering projects.
| 2007- 2008 |
Vice President of Product Operations Celsis In Vitro Inc, Baltimore, MD (Formerly In Vitro Technologies) |
- Worked directly with US, EU and Asian Sales/Marketing to set short and long term production goals, established 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.
- Established working customer complaint and deviation/CAPA system to direct process and product improvements toward customer satisfaction.
- 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, all strategic initiatives.
- Created master database from 8 years of processing data; used data to significantly improve productivity and strategic use of raw materials (human tissues).
- Created databases to manage complex product formulations, QC Data and control inventory.
| 2006 - 2007 |
Senior Director of Commercial Operations Cambrex Bio Science, Baltimore, MD (Now Lonza – Plant Closed) |
- Responsible for all commercial aspects of operations on site including: Project management; client relations and customer service; manufacturing and Quality Control testing schedules and reporting; 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.
| 2004 - 2005 |
Director of Manufacturing and Operations |
- Brought Manufacturing and Quality Control Operations for cellular therapies into GTP compliance.
- 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.
- Managed all QC method, process and facility validations.
- Designed and developed new facilities for both East Coast and West Coast operations.
| 2002 - 2004 |
Vice President of Technical Operations
Biosynexus Inc, Gaithersburg, MD |
- Brought 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, amendments) related to CMC and pre-clinical testing.
- Hosted agency audits resulting in no citations and prepared for pre-approval inspections.
- Negotiated sale of these products to major biopharmaceutical companies.
| 2001 - 2002 |
Senior Consultant, Process and Operations
Biologics Consulting Group LLC |
- Provided quality (QA and QC), technical and operational consulting services to clients. Major project with GATES Foundation to establish international development and manufacturing consortium for MenA vaccine. Projects included: Validation master plans, QC data analysis and reporting, Design and implementation of quality systems programs - testing effectiveness, Regulatory strategy (US, EU and Indian), Over twenty GLP/GMP audits, Due Diligence for merger/acquisitions and investors, International project management, CMO/CRO contracting, Aseptic Processing and Barrier System design and testing
- Wrote and presented courses on Process Validation, QSIT/PAT and upcoming FDA quality initiatives.
| 2000 - 2001 |
Director of Manufacturing
Baxter Hyland Immuno Corporation (formerly NAVA), Columbia, MD |
- Plant Manager reporting to CSO of Immuno Corporation, then to VP of Baxter International Production.
- Direct responsibility for all Vaccine (MenC and Pertusis) Manufacturing, Engineering, In-Process Quality, Facilities, Housekeeping, Environmental Health and Safety, Production Planning and Maintenance - 8 departments with approximately 200 people.
- Took over plant with multiple 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.
- Brought entirely new quality systems approach to site. Worked with Baxter corporate quality leaders to meat standards and qualify for annual quality award.
- Member of corporate committees including Baxter Quality Awards Council (Malcolm Baldridge), Manufacturing Quality Council, Global Readiness committee, SITE Council, etc.
| 1997 - 2000 |
Director of Bioprocessing
Protein Polymer Technologies, Inc., San Diego, CA |
- Senior 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, build-out, and FDA inspection of manufacturing facility.
- Submitted pre-IDE, IDE, IDE supplements and amendments for FDA approval.
| 1993 - 1997 |
Senior Process Development Scientist/Engineer
Bayer Pharmaceuticals, Biotechnology Division, Berkeley, CA |
- 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.
- Served on ELA, INDA, NDA and PLA teams 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 |
Manager of Purification Systems
Berlex Biosciences (formally Codon, Division of Schering A.G.), Richmond, CA |
- Managed 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.
| 1982 - 1987 |
Production Supervisor
Cetus Corporation (now Chiron), Emeryville, CA |
- Supervised 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).
Education
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Continuing education through University of California Extension and MIT Bichemical Engineering B.S. Chemistry(Major) / Physics(Minor), Hayward State University, Hayward CA (1981) B.S. Oceanography, Long Beach State University, Long Beach CA (1978)