Dennis Doody

Professional Profile

Chemical Engineering Management professional with exceptional technical skills and proven leadership abilities, with a track record of successful change implementation using a team-based approach.  Proficient at driving costs out of existing manufacturing processes and developing strategies for the implementation of new technologies.  Strong background in managing GMP regulated pharmaceutical production operations as well as project oversight for facility / equipment design efforts associated with pilot plants, biologics manufacturing facilities, and pre-approval inspection readiness.

Key Accomplishments

  • Upstream Design Lead for new $750M biologics manufacturing facility - process design of media preparation, cell culture, cell separation and inoculum labs.

Results: Produced over 100 P&IDs (piping and instrumentation diagrams), and produced system documentation sets (included system requirements, descriptions, and capabilities documents) for 12 process systems. 

  • Designed, installed, qualified and started-up revisions to pilot scale biologics manufacturing facility in preparation of pre-approval inspection for new drug. Revised over 50 P&IDs; reviewed and approved over 200 detailed piping isometrics. Evaluated regulatory requirements for concurrent production of multiple products. 

Results: Facility passed PAI with no significant observations.

  • Project lead for two design projects in Barceloneta, PR for Reyataz manufacturing and the conversion of a pilot plant to a small scale manufacturing facility.  Both projects involved elements of product containment, from an operator exposure perspective and environmental GMP exposure. 

Results: Overcame cultural barriers to successfully lead team through BOD/CAR submissions. 

  • Reduced operating expenses and led department through two significant projects ($25 million investment) to radically change the penicillin recovery process. 
Results: Increased production capacity by over 15%, reduced labor requirement by 50%, completely eliminated the use of three volatile solvents and reduced emissions of remaining volatile solvent by over 75%.

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Professional Experience

Bristol-Myers Squibb Company  -  Syracuse, New York                                             1989 to 2008

Associate Director Bio/Chem Design – Global Eng, 2/05 – 12/08

  • Supported the design and construction of a large-scale cell culture facility in Devens, MA. Concentrated on the upstream operations including media prep, inoculum prep, cell culture, and harvesting operations. Coordinated efforts with process experts in Syracuse operations, third party support group, and design engineers at the A/E firm.
  • Design Lead for the Building 58 South Suite project. Coordinated design from all disciplines (architectural, mechanical, electrical, automation, and process) to create a “Basis of Design” document with the requisite +/-10% cost estimate and detailed project schedule. 

Principal Engineer – Manufacturing, 6/02 – 2/05

  • Provided support for the antibiotic manufacturing processes in Syracuse Operations, as well as evaluating potential opportunities for new processes.  Prepared numerous “cost of goods” estimates in support of potential business opportunities for the Syracuse site. 
  • Represented TechOps Manufacturing on the design team for the off-shore large scale cell culture facility.
  • Supported Global Engineering in leading the design effort for the PAI Readiness project for building 58B.

Department Manager – Fermentation, 2/99 – 6/02

Managed a large-scale antibiotic fermentation plant for penicillin, cephalosporin, and kanamycin.

  • Responsible for a staff of 27 hourly and 6 supervisory/professionals and a $25 million operating budget.
  • Produced epothilone for clinical supplies. Provided estimate for Syracuse manufacturing costs.
  • Participated in design of fermentation facility for the production of paclitaxel via plant cell platform.
Department Head – Penicillin Extraction, 4/92 – 2/99
Managed a large-scale pharmaceutical facility isolating penicillin V. 
  • Oversaw staff of 21 hourly and 5 supervisory/professionals, and a $38 million operating budget.
  • Coordination of two major process improvement project installations totaling over $24 million capital investment. Significant financial and environmental benefits have been realized.
  • Projects included a paradigm shift from predominantly manual operations to fully automated, thus increasing the complexity of operator training during startup activities.
  • Production output capacity was increased over 15% from 1992 levels.

Process Engineer – Penicillin Extraction, 4/91 – 4/92

  • Supported a penicillin production facility including day-to-day troubleshooting, process improvements and testing, cost reductions, and safety/environmental projects.
  • Designed, installed, and tested a semi-production scale ultrafilter for penicillin whole broth filtration.
  • Initiated database to track performance of the operations including process yields, quality, and RM usage.
Development Engineer – Lactam Pilot Plant, 1/89 – 4/91
  • Scaled up laboratory experiments to pilot plant equipment to prove processes and produce larger quantities of product for further testing. (Cefprozil production, Penicillin V Acid, Enzymatic 7-ACA)
  • Assisted in Belt Filter start-up in the Penicillin Extraction department. Trained off-shift operators and troubleshot operations to maintain acceptable production levels.
  • Designed and installed a pilot scale ceramic ultrafilter system for penicillin broth clarification. Tested various types of filters in multiple configurations in search of optimum performance. 
  • Performed pilot scale testing of spiral wound nanofiltration membranes to support the development of the next-generation penicillin extraction process; eliminating multiple organic solvent steps. 

Rhone-Poulenc Inc.  -  Institute, West Virginia        1986 to 1989
(formerly Union Carbide Agricultural Products Division)


Project Engineer – Plant Engineering Dept., 1/88 – 1/89
  • Managed miscellaneous plant projects through all phases of project life cycle including cost estimating, justification, scheduling, construction/installation, and cost control & tracking.
  • Created a process simulation model for waste piping system to assist in sizing of lift station pumps.
  • Coordinated environmental remediation project associated with underground vessel removal.
Production Engineer – Carbamates Dept., 6/86 – 1/88
  • Supported a pesticide production facility including day-to-day troubleshooting, quality improvements, cost reductions, and safety & environmental projects. (Process utilized methylene chloride as a solvent and methyl isocyanate as a reagent in a highly exothermic reaction.)
  • Using data analysis including SPC tools for justification, instituted a process change to reduce the variability of reagent used and by-products created in the reaction referenced above.Prepared cost estimates for the manufacture of new products using the existing idle equipment. 

Education

  • Syracuse University, Syracuse, NY, in progress (~95% completion)
Coursework toward dual M.S. degrees in Engineering Management & Chemical Engineering
  • Clarkson University, Potsdam, NY - B.S. in Chemical Engineering, 1986
Omega Chi Epsilon - Chemical Engineering Honor Society, Tau Beta Pi - Engineering Honor Society