James Evans

James Evans

Location
Greater Boston Area
Industry
Pharmaceuticals

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James Evans's Overview

Current
  • Director API Technical Services at Hospira
Past
  • Director Manufacturing Science and Technology at Hospira
  • Associate Director - Novartis/MIT Center for Continuous Manufacturing at MIT
  • Scientist II at Vertex Pharmaceuticals
Education
Connections

500+ connections

James Evans' Summary

A technical innovator with experience in leading highly effective goal oriented global multi-disciplinary teams, specializing in technology driven innovative advances in the design, optimization and scale up of processes for the manufacturing of both active pharmaceutical ingredients and Oral Solid Dosage forms, with broad global experience across all scales and stages of development.

With over 7 years experience as a team lead/group director, blending technical project management with people and team leadership.


Specialties: Technology strategy development and implementation, R&D project management, chemical and formulation process development, optimization, manufacturing and technical transfer, team building, Six Sigma/Lean principles, Return on Investment assessment, coaching/mentoring individuals and teams, people leadership.

James Evans' Experience

Director API Technical Services

Hospira

Public Company; 10,001+ employees; HSP; Pharmaceuticals industry

August 2014Present (2 months) Lake Forest, IL

Director Manufacturing Science and Technology

Hospira

Public Company; 10,001+ employees; HSP; Pharmaceuticals industry

May 2013August 2014 (1 year 4 months) Boulder, Colorado Area

Associate Director - Novartis/MIT Center for Continuous Manufacturing

MIT

December 2007May 2013 (5 years 6 months)

Overall responsibility for the strategy and focus of the research activities of a group of scientists, engineers and a project manager. This group has been tasked with delivering transformational technology for both drug substance and drug product pharmaceutical manufacturing with the end goal of delivering an integrated manufacturing process. Additional responsibilities include the development of both short and long term strategies for the center as a whole, design and management of a multimillion dollar continuous manufacturing facility that is capable of handling a wide range of API’s and all phases of pharmaceutical research, technology scouting, procurement and logistics. I also act as an interface between potential industrial and academic partners.

Scientist II

Vertex Pharmaceuticals

Public Company; 1001-5000 employees; VRTX; Pharmaceuticals industry

October 2007December 2007 (3 months)

Chemical development with a specific emphasis on crystallization, filtration and drying

Public Company; 1001-5000 employees; VRTX; Pharmaceuticals industry

April 2006October 2007 (1 year 7 months)

Chemical Development with a specific emphasis on crystallization, filtration and drying

Senior Physical Chemist

GlaxoSmithKline

Public Company; 10,001+ employees; GSK; Pharmaceuticals industry

20022005 (3 years)

Physical properties analysis, Technical transfer of analytical methods and synthetic routes, technical support, troubleshooting for the manufacturing teams

Senior Postdoctoral Research Associate

Illinois Institute of Technology

Educational Institution; 1001-5000 employees; Higher Education industry

20002002 (2 years)

Fundamnetal research on nucleation phenomena

Development of Non Photochemical Laser induced nucleation technology for proteins

PhD Student

Herriott Watt University

19972000 (3 years)

Crystallization and Molecular Modeling studies of a pharmaceutical intermediate

James Evans' Courses

  • Massachusetts Institute of Technology - Sloan School of Management

    • Managing Technical Professionals and Organizations
    • Transforming your Leadership Strategy
    • Building, Leading, and Sustaining the Innovative Organization
    • Supply Chian Strategy and Management
    • Developing a Leading Edge Operations Strategy
  • Scientist II

    Vertex Pharmaceuticals

    • Six Sigma Green Belt

James Evans' Skills & Expertise

  1. Process Development
  2. Crystallization
  3. QbD
  4. Continuous Process Development
  5. Six Sigma
  6. Project Management
  7. Continuous Manufacturing
  8. Process Integration
  9. Process Engineering
  10. Process Analytical Technology
  11. Design of Experiments
  12. Quality by Design
  13. Chemical Engineering
  14. Pharmaceuticals
  15. DOE
  16. Minitab
  17. Lean Manufacturing
  18. 5S
  19. Green Belt
  20. Pilot Plant
  21. Strategic Planning
  22. Continuous Process
  23. Technology Transfer
  24. Pharmaceutical Industry
  25. Process Simulation
  26. Chemistry
  27. Biotechnology
  28. Drug Delivery
  29. HPLC
  30. Organic Chemistry
  31. UV/Vis
  32. Characterization
  33. Spectroscopy
  34. Drug Development
  35. Organic Synthesis
  36. R&D
  37. GMP
  38. Chromatography
  39. Analytical Chemistry
  40. Drug Discovery
  41. Purification
  42. Medicinal Chemistry
  43. LC-MS
  44. Biopharmaceuticals
  45. NMR
  46. Validation
  47. GLP
  48. Mass Spectrometry
  49. FDA
  50. Lifesciences

View All (50) Skills View Fewer Skills

James Evans' Publications

  • Economic Analysis of Integrated Continuous and Batch Pharmaceutical Manufacturing: A Case Study

    • ACS
    • July 27, 2011
    Authors: James Evans, Spencer D. Schaber, Paul I. Barton, Bernhardt Trout, , Rohit Ramachandran

    The capital, operating, and overall costs of a dedicated continuous manufacturing process to synthesize an active pharmaceutical ingredient (API) and formulate it into tablets are estimated for a production scale of 2000 t of tablets per year, with raw material cost, production yield, and API loading varied over broad ranges. Costs are compared to batch production in a dedicated facility. Synthesis begins with a key organic intermediate three synthetic steps before the final API; results are given for key intermediate (KI) costs of $100 to $3000/kg, with drug loadings in the tablet of 10 and 50 wt %. The novel continuous process described here is being developed by an interdisciplinary team of 20 researchers. Since yields are not yet well-known, and continuous processes typically have better yields than batch ones, the overall yields of the continuous processes with recycling were set equal to that of the batch process. Without recycling, yields are 10% lower, but less equipment is required. The continuous process has not been built at large scale, so Wroth factors and other assumptions were used to estimate costs. Capital expenditures for continuous production were estimated to be 20 to 76% lower, depending on the drug loading, KI cost, and process chosen; operating expenditures were estimated to be between 40% lower and 9% higher. The novel continuous process with recycling coupled to a novel direct tablet formation process yields the best overall cost savings in each drug loading/KI price scenario: estimated savings range from 9 to 40%. Overall cost savings are also given assuming the yield in the continuous case is 10% above and 10% below that of the batch process. Even when yields in the continuous case are lower than in the batch case, savings can still be achieved because the labor, materials handling, CapEx, and other savings compensate.

  • SAXS Study of the Nucleation of Glycine Crystals from a Supersaturated Solution

    • ACS
    • February 2, 2005
    Authors: James Evans, Soma Chattopadhyay, Allan Myerson, Carlo U. Segre, Jan Ilavsky, Deniz Erdemir, Heinz Amenitsch

    Nucleation of crystalline solids, the first stage of crystallization from solution, is not yet fully understood. This is true for both small molecules of low molecular weight and more complicated large molecules. To obtain direct structural information about the process of nucleation and crystallization of small molecules, small-angle X-ray scattering (SAXS) has been used to study the crystallization of the amino acid glycine from its supersaturated aqueous solution. The scattering data was analyzed using the unified fit model, which is well-suited for studying complex systems that may contain multiple levels of related structural features. The results suggest that glycine molecules exist as dimers in supersaturated solution. The system obeys power-law behavior that indicates the presence of fractals in the solution. A transformation from mass fractal structure to surface fractal structure is observed during the crystallization process, which could be the signature of a two-step nucleation process

  • Pharmaceutical Crystallization

    • ACS
    • February 22, 2011
    Authors: James Evans, Allan Myerson, Jie Chen, Bipul Sarma

    Crystallization is crucial in the pharmaceutical industry as a separation process for intermediates and as the final step in the manufacture of active pharmaceutical ingredients (APIs). In this perspective article to celebrate 10 years of Crystal Growth & Design, we focus on three areas related to crystallization in the pharmaceutical industry: (1) advances in our understanding of the fundamentals of nucleation, (2) production and scale-up of novel solid forms, and (3) continuous processing. While the areas discussed are not new, they are areas, in our opinion, of significant current interest to the community engaged in crystallization in the pharmaceutical industry.

  • Capacity Planning under Clinical Trials Uncertainty in Continuous Pharmaceutical Manufacturing, 2: Solution Method

    • American Chemical Society
    • October 9, 2012
    Authors: James Evans, Paul I. Barton, Arul Sundaramoorthy, Xiang Li


    In Part 1 of this paper, we presented a scenario-based multiperiod mixed-integer linear programming (MILP) formulation for a capacity planning problem in continuous pharmaceutical manufacturing under clinical trials uncertainty. The number of scenarios and, thus, the formulation size grows exponentially with the number of products. The model size easily becomes intractable for conventional algorithms for more than 8 products. However, industrial-scale problems often involve 10 or more products, and thus a scalable solution algorithm is essential to solve such large-scale problems in reasonable times. In this part of the paper, we develop a rigorous decomposition strategy that exploits the underlying problem structure. We demonstrate the effectiveness of the proposed algorithm using several examples containing up to 16 potential products and over 65 000 scenarios. With the proposed decomposition algorithm, the solution time scales linearly with the number of scenarios, whereby a 16-product example with over 65 million binary variables, nearly 240 million continuous variables, and over 250 million constraints was solved in less than 6 h of solver time.

  • Bye Bye Batch

    • The Chemical Engineer
    • February 2013
    Authors: James Evans

    This paper provides a high level overview of the Novartis-MIT vision of integrated continuous manufacturing of pharmaceuticals products. As well as providing some details about the successful implementation of the concept at our pilot facility.

  • End-to-End Continuous Manufacturing of Pharmaceuticals: Integrated Synthesis, Purification, and Final Dosage Formation

    • Angew. Chem. Int. Ed Wiley
    • October 2013
    Authors: Patrick Heider, Salvatore Mascia, Haitao Zhang, Richard Lakerveld, James Evans, brahim benyahia, Bernhardt L Trout, Charles L Cooney, Timothy F Jamison, Klavs F Jenssen, Allan S Myerson

    The continuous manufacture of a finished drug product starting from chemical intermediates is reported. The continuous pilot-scale plant used a novel route that incorporated many advantages of continuous-flow processes to produce active pharmaceutical ingredients and the drug product in one integrated system.

  • Application of Continuous Crystallization in an Integrated Continuous Pharmaceutical Pilot Plant

    • ACS
    • April 2014

    Real-time control using process analytical technology (PAT) tools is required for the implementation of continuous crystallization within integrated continuous manufacturing (ICM) of pharmaceuticals. However, appropriate selection of PAT tools is challenging, and the design and operation of automated control loops for continuous crystallization within a continuous pharmaceutical process brings forward important questions. This paper discusses the process design and operation of a continuous reactive crystallization of aliskiren hemifumarate as part of an ICM pilot plant. Several PAT tools were used within automated control loops to satisfy specifications on the critical materials attributes of the crystallization process. The operational performance of the process was maintained for periods of time over 100 h. The purity of the targeted product exceeded 99%, and the process yield reached 91.4%

  • Development of a Multi-Step Synthesis and Workup Sequence for an Integrated, Continuous Manufacturing Process of a Pharmaceutical

    • ACS - OPRD
    • February 2014

    The development and operation of the synthesis and workup steps of a fully integrated, continuous manufacturing plant for synthesizing aliskiren, a small molecule pharmaceutical, are presented. The plant started with advanced intermediates, two synthetic steps away from the final active pharmaceutical ingredient, and ended with finished tablets. The entire process was run on several occasions, with the data presented herein corresponding to a 240 h run at a nominal throughput of 41 g h–1 of aliskiren. The first reaction was performed solvent-free in a molten condition at a high temperature, achieving high yields (90%) and avoiding solid handling and a long residence time (due to higher concentrations compared to dilute conditions when run at lower temperatures in a solvent). The resulting stream was worked-up inline using liquid–liquid extraction with membrane-based separators that were scaled-up from microfluidic designs. The second reaction involved a Boc deprotection, using aqueous HCl that was rapidly quenched with aqueous NaOH using an inline pH measurement to control NaOH addition. The reaction maintained high yields (90–95%) under closed-loop control despite process disturbances.

  • The Application of an Automated Control Strategy for an Integrated Continuous Pharmaceutical Pilot Plant

    • Organic Process Research & Development
    • August 1, 2014
    Authors: James Evans, Brahim Benyahia, Richard Braatz, Richard Lakerveld, Patrick Heider, Haitao Zhang, Aaron Wolfe, Christopher Testa, Sean Ogden, Salvatore Mascia, Paul I. Barton

    Continuous manufacturing offers potential opportunities for the improved manufacturing of pharmaceutical products. A key challenge is the development of an appropriate control strategy. The experimental application of an automated control strategy is presented for an end-to-end continuous pharmaceutical pilot plant. The process starts from an advanced intermediate compound and finishes with the tablet formation steps. The focus of the experimental results is on the design and performance of the control loops needed to produce a slurry of an active pharmaceutical ingredient and a solvent with specified material properties. The results demonstrate that automated control can successfully keep critical material attributes close to the desired set points for a sustained period of operation. This work aims to contribute to the development of future continuous pharmaceutical processes by providing a realistic case study of automated control of an integrated, continuous, pharmaceutical pilot plant.

James Evans' Education

Heriot-Watt University

PhD, Chemical Engineering

19972003

Thesis Title 'Structuro-Kinetic Process Assessment of the Batch Crystallization of Phenoxyacetic Acid: A Molecular Perspective'

The University of Manchester

MS, Instrumentation and Analytical chemistry

19951996

University of Sunderland

BS, Enviornmental Studies

19921995

James Evans' Additional Information

Groups and Associations:
Honors and Awards:

2006 Awarded O visa

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