Pharmaceutical Powder and Spray Drying Expert

Expertise

• Theory, design, applications and practice of Spray drying and powder technologies of forty years in the following areas:
• Formulation development, design, characterization and processing of powder based materials, with associated engineering and analytical sciences.
• Equipment design and fabrication, component specification, vendor selection, and procurement
• Process design, instrumentation and control.
• Equipment manufacturing design and delivery of spray dryers and other capital equipment projects.
• Application development for diverse industries: Industrial chemicals, food, dairy and pharmaceuticals.
• Troubleshooting and addressing technical issues for clients.
• Domestic and international field installation, commissioning, and operations turn-over.
• Quality by Design (QbD) GMP formulation and process development, technical transfer, scale-up and validation.
• Communications (written, oral and presentation), with all levels in the organization and diverse customer, vendor, contractor, regulatory, and legal representatives.
• Contract development and negotiation.

Expert Witness Experience

• Product Liability Defect, spray dryer fuel gas explosion, (involving fatality).
• Product Liability Defect, faulted activation of fire suppression system, lost production.
• Failure to Warn, tank truck CIP chemical reaction to carbon monoxide, (involving fatality).
• Failure to Perform and Breach of Contract, failed design revisions to FilterMat dryer assigned to low yield, claimed sales misrepresentation of earlier installations.
• Other legal support: Hazard assessments, root cause analysis, depositions, and regulatory environment permit filings with locations in New York, Wisconsin, California, Maryland Alabama,and Delaware).

Experience

Undisclosed Company, President, 2015 - Present

Owner - Senior Consultant

• Innovative yet practical problem-solving for spray drying product applications, process optimization, and ancillary equipment design and operation.
• Delivers: Formulation, process systems, hands on trouble shooting, manufacturing operations practices, food and pharmaceutical regulatory compliance, training, QC methods.
• Retrofitting enhancements and conversions for new products, capacity optimization and product versatility
• Installation of new systems as either bespoke design by S2P or providing client support and advocacy in specification, vendor selection and installation and commissioning execution with other manufacturers.
• Development of novel mechanisms and processes for exclusive, high value added, applications.
• Design, engineering and permit application of a utility solvent emissions abatement system for a major pharmaceutical companies.
• The survey of a tolling company's uniquely altered legacy dryer installation and operation addressed its capabilities in drying difficult fruit products. Services included requested recommendations as to staffing and business processes as well as technical input.
• Liaison to a drug discovery company in Phase 3 contract manufacturing, the scope of work includes process optimization, directing development experiments to the product's CQA. The client is anticipating that commercialization will require capitalization of a new spray dryer and would like support in its specification, vendor selection and delivery. The client expectations fulfilled in each case.

Ashland Specialty Ingredients, Columbia, MD, 2014

Senior Project Leader, For the Center of Excellence for Drug Solubilization

• Ashland is a global leader in providing specialty chemical solutions to customers in a wide range of consumer and industrial markets, including architectural coatings, automotive, construction, energy, food and beverage, personal care and pharmaceuticals.
• Solid dispersion compositions; OSD formulation and clinical trial manufacturing under contracts and in-house research and development for new applications and promotion of Ashland's excipients.
• Apply and interpret scientific and engineering principles to direct and oversee project leaders and analytical scientists in project execution.
• Responsible for client's full satisfaction of objectives. Pre-sales client presentations, preparation of scope of work statements and contracts.
• Principal author and reviewer of technical reports.
• Participated in the evolution of solid dispersion formulation, processing, and characterization of the amorphous state, chemical and solid state stability. Submitted creative approaches to the experimental design, characterization and functionality of amorphous solid dispersions.
• Hands on analyses including: the amorphous state by thermal (mDSC, TGA), hot-stage polarized light microscopy and powder x-ray diffraction, and functionality (enhanced bio-availability) including supersaturated dissolution (PION uDiss%u2122).
• In addition to primary role, recognized as corporate SME for internal production spray drying of polymers for ASI's industrial, foods, personal care and pharmaceutical excipients markets.
• Bio-availability enhanced solid dispersion formulation and clinical trial manufacturing in fee-for-service contracts.
• In house research and development for new applications and promotion of Ashland's excipients.
• Creative approaches to the experimental design and characterization of amorphous solid dispersions.
• Analyses including: thermal (TA Instrument Q2000 mDSC, Q500 TGA), particle size (laser diffraction Horiba, Malvern), dissolution (supersaturated PION uDiss%u2122), hot-stage polarized light microscopy (Brinks Systems), and powder x-ray diffraction (Bruker D8 Focus).
• Drug product commercial launch, modified existing spray dryer for a 150% capacity increase. prepared and executed the supporting DOE and product process validation.
• In addition to primary role, recognized as corporate SME for internal production spray drying of polymers for ASI's industrial, foods, personal care and pharmaceutical excipients markets.

Niro Pharma Technologies, Columbia, MD, 1992 - 2014

Project Leader Formulation Development Services

• Principal gateway between clients' needs and organization at large in contract formulation development and manufacturing of solid dosage form pharmaceuticals. Led multidisciplinary project team applying QbD in research and development formulation, process development and technical transfer to cGMP compliant production.
• Coordinated adaptation of client raw material and product release criteria, cleaning verification, equipment qualification, sampling etc., in close cooperation with QA, QC analytical laboratory, engineering, and production departments.
• Expert process knowledge of spray drying, fluid bed processors (dry, granulate, coat), high shear wet granulation, extrusion, and tablet compression, coating and printing.
• Other firsthand experience with crystallization, pasteurization, fermentation, cell disruption, evaporation, distillation, membrane filtration.

Niro Inc., Food and Dairy Division, River Falls, WI, Pilot Plant Manager, 1992 - 1998

• Managed pilot service facilities to demonstrate and prove applications of capital equipment offerings for food and dairy applications in spray drying, fluid bed drying and agglomeration, falling film evaporators, membrane filtration and separations, centrifugal separators, and powder packaging. Hands on customer testing, development and pilot services as process test engineer.
• Customer testing, development and pilot services as process test engineer with responsibilities that included staffing, budget, regulatory compliance, and market promotions.
• Client driven programs entailed one to one correspondence and worked with their technical staff. Internal reporting to sales and process design included commercial considerations as well as technical information.
• Responsibilities included staffing, budget, regulatory compliance, and market promotions.
• Instigated and negotiated IP rights for sole source contract with a major pharmaceutical company.
• Supported deliverables' design, defined control schema for PC/PLC execution.
• Assigned to develop and manage standard P&ID and controls system for complex FilterMat%u2122 dryers.
• Principal process engineering representative for on-site commissioning.

Damrow Company, Fond du Lac, WI, Manager of Technical Services, 1967 - 1992

• Darrow Company is a division of Carlisle Process Systems, that manufactures cheese-making equipment such as curd strainers, forming towers, grinders and extruders, and vats.
• Manage Technical Services and research and development activities across spray dryer and cheese making equipment lines. Many hats worn in engineering and delivering commercial spray drying systems and cheese plants including FilterMat%u2122 and tall-form spray dryers, cheese vats, finishing tables, block formers, bulk milk systems, pasteurization, separators, and CIP systems.
• Duties included: pilot plant application development, design and execution of instrumentation and control package and extensive field work.
• Installation and commissioning of systems (2 and 3 per year, North America and Europe) required assertively taking charge and directing owner's installation sub-contractors and operations staff in co-ordination with Damrow's own mechanical and engineering field crews, typically 20 to 30 personnel overall.
• Developed and commercialized innovative processes and equipment configurations (including a closed cycle FilterLab%u2122 for organic solvents, spray congealing, integrated fluid bed spray dryer/agglomerator) that in addition to dairy and foods, opened new markets in pharmaceuticals and sugars resulting in sales of $6 million

American Custom Drying Co, Burlington, NJ, Manager of Engineering and Operations, 1983 - 1987

• American Custom Drying Company offers contract spray drying and custom blending services to the food and chemical industries.
• Executed technical and organizational restructuring to convert a dedicated caseinate production facility to contract processing business.
• Added piloting facilities, upgraded existing liquid formulation and drying equipment for versatile utilization in new applications including foods and flavors and specialty polymers.
• Designed and engineered new drying plant for expansion adding one of the earliest integrated fluid bed spray dryers.
• Wrote and implemented: business and market plan (secured $1.5 million financing for new dryer project), sales systems, client contracts, regulatory safety and environmental policy and procedures, Drug Master File, SOP's, capital investment and maintenance budgets.
• Increased sales and margins by multiples year over year from inception.
• Attracted prestigious clientele including Merck for which ACD was a key supply chain partner in launching their blockbuster Lovastatin (Mevacor), the first anti-cholesterol medication. (Other clients: Rohm and Hass, Nalco, Kraft Foods, IFF, and M&T Chemicals).
• Built on these foundations, ACD has since grown to become one of the largest contract spray drying facilities.

Dominion Foods, NV, St. Maarten, Netherlands Antilles, Consulting Manager, 1982 - 1983

• Start-up of new beverage company by refurbishment of milk recombining plant to produce packaged high quality whole milk and other consumer beverages.
• Administrative, technical, and public relations responsibilities included in small scale but comprehensive business venture.
• The business included philanthropic intentions to improve the welfare of the native residents in cooperation with a local community organizer.
• Success achieved in an especially challenging cultural environment.

Stork-Bowen Engineering, Inc., Somerville, New Jersey, Manger, Technical Services, 1974 - 1982

• Stork-Bowen provided process engineering, design and delivery of spray, flash and fluid bed dryer. Acquired by Niro.
• Rapid progression of responsibilities starting from assistant technician position in pilot plant and advancing to executive staff accountability in five years.
• Extensive fieldwork delivering technical services and commissioning included liberal authority as sole site representative to client of contracts valued from $50,000 to $5 million.
• International experience in Canada, Mexico, Columbia, South Korea, Caribbean, and Europe.
• Custom drying and processing systems delivered to diverse industries, worldwide, and government agencies (DOE, DOD), for production of fine and commodity chemicals, foods, coffee, flu gas sulfur emissions control, waste remediation.
• Equipment expertise: Direct combustion air heating, burner safety, fans and pressure blowers, metering and high pressure pumps, high shear mixers, atomizing nozzles, high speed rotary atomizers and drives (direct motors up to 75HP at 24,000 RPM, geared transmissions to 200HP at 12,000 RPM), variable frequency drives (including prototype to 400 Hz), Schugi%u2122 agglomerating mixer, Grenco%u2122 freeze concentrator, cyclones and filter bag powder collectors, scrubbers, coffee extractors and "instantizer", falling film evaporators, heat recovery, electromechanical and pneumatic instruments and controls.
• Recognized for outstanding troubleshooting skills and process know how.

Honors & Publications

Academic and Professional Affiliations

• AAPS (American Association of Pharmaceutical Scientists)
• ISPE (International Society of Pharmaceutical Engineers)

Publications

• Pharmaceutical spray drying and hot melt extrusion of bio-availability enhanced solid dispersions
• "Process Drying Practice"

Education

• Bio-Medical Engineering Studies, Worcester Polytechnic Institute, Worcester, MA