Mitch Simmonds Email & Phone Number

Burlington, MA, US

• Develop, optimize, and characterize upstream and downstream processes in various stages of clinical trials for multiple types of viruses used in gene therapy applications
• Tech Transfer of internal platform process – use process transfer document to execute process, adapt to GMP requirements, define operational limits for manufacturing
• Interact with clients and assess program needs, design studies within scope of task order
• Plan, design, and execute process development experiments for client and internal projects
• Work cross-functionally and within project team to meet deliverables per project timelines
• Analyze samples, draft summaries and reports, present data to stakeholders

Burlington, MA, US

• Contract Manufacturing of gene therapy products for phase I - III clinical studies and commercial use
• Utilize infection and transfection methods to produce CAR-T, AAV, lentivirus, coxsackievirus, reovirus, and retrovirus therapies
• Lead manufacturing operations on a 130L bioreactor process: coordinate scheduling, materials, and personnel to adhere to project timeline; ensure team's compliance to batch records and SOPs; report updates at client.
• Train technicians, leads, and supervisors using advanced knowledge and understanding of process-related scientific principles
• Support Tech Transfer and Process Development in implementing new products and processes into GMP manufacturing
• Write and amend SOPs, batch records, reports, item specifications, and other documentation

Burlington, MA, US

• Perform adherent cell culture employing T-flasks, CellStacks, HyperStacks, and iCELLis Bioreactors
• Perform suspension cell culture using Erlenmeyer flasks, WAVE bioreactors, Single-Use Disposable bioreactors, and stainless steel bioreactors
• Perform downstream processing utilizing depth filtration, tangential flow filtration, ultrafiltration/diafiltration, column chromatography (AEX, IEX, SEC, GPC)
• Executed process, equipment, systems and utilities, qualification, and validation protocols
• Track and trend production data
• Determine materials necessary for GMP operations and coordinate scheduling with Materials team

Newark, Cafilfornia, US

• Process Development Responsibilities: Jan. 2016 - Aug. 2016
• Scaled up a disposable bioreactor program
• Phenotyped new cell lines by performing flow cytometry with two colors
• Developed automated cell counting methods
• Conducted volume reduction experiments by continuous centrifugationResearch Responsibilities: Jan. 2016 - Aug. 2016
• Sectioned brain and retinal tissue and performed immunohistochemical staining

San Rafael, CA, US

• Received and processed samples using LIMS, assigned samples to proper assays for testing, ensured proper storage of samples
• Conducted A280 protein concentration assay (Bradford's assay) to test product quality
• Prepared reagents for use in assays or cleaning of equipment
• Performed required documentation to comply with cGMP and cGLP requirements
• Implemented 5S principles into lab space
• Performed maintenance of laboratory equipment and housekeeping operations

West Lafayette, IN, US

• Determined density and porosity of foods using computed tomography x-ray scanner for industrial uses
• Designed and executed experiments, data collection, and analysis
• Reduced error in computations by 25% by identifying problems and revising analysis procedures
• Collaborated with supervisors weekly to discuss experiment results and future goals
• Acknowledged for the contribution of data collection in the following manuscript:Kelkar, Shivangi; Boushey, Carol J; Okos, Martin. "A Method to Determine the Density of Foods using X-ray Imaging." Journal of Food.

West Lafayette, IN, US

• Developed a zero-discharge plant to freeze concentrate wine for uses in the food and beverage industries
• Created algorithm to model freeze concentration process over time based on thermal and physical properties of the product
• Calculated time and energy requirements for the process using changes in enthalpy, density, heat capacity, thermal conductivity, thermal diffusivity and composition concentrations
• Measured results of experimental process by finding degrees Brix, specific gravity, density, pH, and ethanol content using a pycnometer and spectrophotometer
• Used algorithm calculations to determine the scale of equipment necessary to produce desired quantity
• Optimized cost of equipment vs. operating cost in economic analysis

Novato, CA, US

• Analyzed the effects of a high-fat diet in wild-type and transgenic mice and correlate results to glucose consumption, insulin production, diabetes and longevity
• Phenotyping of wild-type and transgenic mice: Collected histological and immunohistochemical data and analyzed results using ImageJ analysis program
• Genotyping of wild-type and transgenic mice: isolated DNA, RNA and proteins through PCR, gel electrophoresis and Western Blot techniques
• Instructed first-year interns in proper lab etiquette, techniques, procedures and protocols

• Tutored high school students in Algebra I and II, Biology, English, Geometry, Physics, Physiology, and World History
• Customized lesson plans, resulting in a full grade increase for 100% of students

Novato, CA, US

• Phenotyping of wild-type and transgenic mice: Collected histological and immunohistochemical data
• Genotyping of wild-type and transgenic mice: isolated DNA, RNA and proteins through PCR, and gel electrophoresis

• Tutored high school students in Algebra I and II, Biology, English, Geometry, Physics, Physiology, and World History
• Customized lesson plans, resulting in a full grade increase for 100% of students

• Tutored high school students in Algebra I and II, Biology, English, Geometry, Physics, Physiology, and World History
• Customized lesson plans, resulting in a full grade increase for 100% of students

Oakland, California, US

• Taught Geometry to 29 high school students from disadvantaged backgrounds
• Created lesson plans, administered tests, grading andand provided individual instruction as needed