Head of the Process Analytical Technologies and Automation R&D team

leading a multidisciplinary team of scientists evaluating state of the art mammalian biotech manufacturing process improvements, in-line analytics, and automation. Identify ways for improving manufacturing throughput and reduction of cost of goods. Focus on biologic production facilities of the future, while playing a key role in strengthening Lonza's current manufacturing assets. Proven success of transferring novel technological improvements to the manufacturing floor, realizing time savings and process robustness. Dedicated leader with focus to identifying, building, and maintaining a best in class team of scientists and engineers. Focus on individual team members growth while keeping a balance with a great team atmosphere.

Mammalian Research and Technology CMO

Process Development Scientist III, MSAT Purification: Develop and guide purification process transfers from client facilities or internal development groups.Interact with customers as the primary interface for the scientific and technological aspects of protein therapeutic manufacturing.Create process scale up from pilot lots to 5,000 litre bioreactors, utilizing 80cm chromatography columns.Support commercial manufacture in 20,000 litre bioreactors, utilizing 2m, 1.4m, and 1.0m chromatography columns.Point of contact for customers Person-In-Plant while manufacturing activities are ongoing.Work with customers and manufacturing on any required process modifications, through regulated change control systems.Provide technical consult, Subject Matter Expert, to deviation and investigation reports and author reports as appropriate.Work with technical writing group for creating master batch records, ownership responsibility once created.Provide process training and on-floor support to manufacturing and data entry administrators for process data.Develop processing monitoring tools using PI, ProcessBook, Delta V.Maintain and use databases and statistical applications, author control charts, create higher level statistical analysis.Identify process improvement opportunities and cost reduction potentials for purification processes.Participate in customer audits and regulatory inspections as the principal scientific expert.Understanding of cGMP guidelines, regulations. Support for PAI, sBLA submissions.Support capitol engineering projects as the scientific advisor.Create facility fit evaluations for new transfers, process improvements, including all aspects of manufacturing.Supervise and guide the career development of direct reports.Mentor junior team members, and take lead in developing team projects, discussions.

Specialist, Protein Purification: 12/03 to 6/06Project management of new development and manufacturing cGMP projects. Create project timelines and plan resource usage, using Microsoft Project.Interface with the client as the subject matter expert during technology transfers and process development.Support regulatory efforts, including inspections and responses. Create batch records, SOP’s, and specifications.Source raw materials and specialty equipment for cGMP manufacture.Key role in the design renovations of the purification manufacturing facility build for disposable and expanded capability.Develop single use disposable purification processes, inclusive of bags, skids, mixers, novel disposable skids.Primary project manager of the scope/design/procurement of purification skids.Responsible for the oversight of FAT/SAT and oversight of the IQ/OQ/PQ process.Manage junior level scientists; plan and supervise their purification development projects.Train and guide manufacturing personnel and associate scientists in analytical and preparatory purification techniques.

Senior Laboratory Scientist, Protein Purification: 6/00 to 12/03Responsibilities include purification development for novel synthetic antibodies and recombinant proteins.Research process improvement techniques to optimize recovery, decrease process length, and decrease raw material costs.Develop automated purification methods using Perseptive and GE Healthcare Akta chromatography platforms.Examine the feasibility of novel chromatography resins in new and existing purification processes.Develop ultrafiltration membrane absorption and scaling experiments.Perform cGMP manufacture of injectable antibody products at a 50L and 2000L scale.Investigate assays to assist in the design of purification processes, example antibody quantitation, quality, etc. Implement lab-on-a-chip equipment, including the transfer and qualification of older assays to the new technology.Scout and enhance assay tools for residual elements in purification processes.Run traditional analytical assays; ELISA, Endotoxin, SDS-PAGE, immunoblotting and total protein determination. Lab supervisor for preventative maintenance and repair of HPLC, FPLC, and analytical equipment.

Scientist I: 1/98 to 6/00Perform cGMP purification of recombinant viral proteins for clinical use, 50L to 400L.Optimization studies for the purification process of recombinant viral proteins.Perform column chromatography Explore new technology for protein separation, including a membrane bound ion-exchange system.Use analytical techniques including SDS-PAGE, western blotting, ELISA and Bradford assays.Develop an experimental colorimetric assay to quantify residual Sodium Thiocyanate.Design ultrafiltration process for the manufacture of vaccine products.Involved in the scale-up of experimental chromatography to process scale chromatography.Purify monoclonal antibodies for use in immunoaffinity chromatography.Develop purification processes for novel virus-like particles.

Purify enzymes using filtration, ion exchange, and size exclusion liquid chromatography.Analyze enzymes using HPLC and SDS-PAGE gel electrophoresis.Follow purification steps with the use of Phast gel electrophoresis system and conventional SDS-PAGE.Design and carryout own experimentation in developing purification methods for enzymes.Keep detailed laboratory notebooks and all required documentation.

Research experimental media for the fermentation of Penicillium chrysogenum.Prepare and maintain stock cultures of Penicillium chrysogenum for strain improvement studies.Analyze cellular production of penicillin using quantitative HPLC.Trouble-shoot production strain improvement operating procedures and optimize. Design and carryout own experimentation in developing purification methods for enzymes with assistance.Keep detailed laboratory notebooks and all required documentation