Mitch Simmonds Email & Phone Number

Carlsbad, Ca, Us

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• Create transfer documents and direct the Technology Transfer team to move projects into GMP• Present clients’ program development to leadership team, deliver go/no-go statements on manufacturing readiness, define need for further studies if necessary, draft risk assessment• Execute process validation protocols – media hold studies, process characterization• Support Validation by performing IQ/OQ of equipment; performed studies for validating autoclave loads; created and revised SOPs for validated processes

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 meetings• 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• Program temperature probes and analyze data for validating autoclave loads• Perform IQ/OQ on stainless steel and single-use bioreactors• Conduct individual and group training on the use of equipment, processing steps, process changes, and safety procedures

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• Analyzed images of stained sections to quantify cellular engraftement and myelinationManufacturing Responsibilities: Sep. 2014 - Aug. 2016• Executed processes for GMP culture-expansion and cryopreservation of stem cell and progenitor cell products• Formulated Final Product lots for transplantation in adults with ASIA A and ASIA B spinal cord injuries• Determined materials necessary for GMP operations and coordinated scheduling between Manufacturing and Materials Management• Created cost analysis of materials, reagents, time, and personnel required to produce Working Cell Bank and Final Product lots, including media and process intermediates production• Implemented Kanban system in the clean rooms and trained personnel on its use and maintenance• Compiled historical working cell bank and patient production data and performed trending analysis

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 Engineering, vol. 159, 2015, pp. 36-41

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