Shawn Keil Email and Phone Number
Shawn Keil work email
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Shawn Keil personal email
Experienced Research Scientist and Laboratory Manager with 10+ years of managing a GLP compliant lab and over 20+ years of hands-on microbiology experience. I enjoy strong collaboration within the cross-functional team environment, and I strive to produce scientifically sound results by utilizing a detail-oriented approach. As an independent thinker, I enjoy combining my attention to detail with my strong technical background in microbiology and regulatory compliance to provide out of the box thinking to solve problems. I apply extensive experience as a successful team leader to ensure that the right talent and approach are brought to every situation. I continue to look forward to the challenge of growing myself both personally and professionally.Key Skills: • 21 CFR part 58 / 21 CFR part 820 / ISO 13485 / ISO 17025 / MDD / MDR• Hematology and coagulation assays• Lab safety (BSL-2)• Assay validations / equipment qualifications• Biostatistics (minitab)• CAPA• Internal/external audits• Mammalian cell culture• Manuscript preparation / review• Office suite (Excel, Word, PowerPoint)• Microbiology assays (TCID50, plaque, CFU)• Protocol development / review• Project management / scientific strategy• Lab management / associate development
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Women'S Club Soccer Head CoachColorado School Of Mines Sep 2003 - PresentGolden Colorado• Qualified for National Club Soccer Championship Tournament - 2009, 2011, 2014, 2015. 2016• CSM club coach of the year - 2009 -
Laboratory Scientific ManagerTerumo Blood And Cell Technologies Dec 2011 - Nov 2022• Responsible for the equipment qualification, assay validation, and GLP programs• Actively managed and mentored up to 10 associates / contractors / interns • Assisted the Scientific Affairs Director in laboratory budgets and capital expenditures requests• Conducted scientific and clinical site audits of suppliers as part of the approved supplier process• Reviewed and approved both departmental quality procedures and laboratory operating procedures in compliance with 21 CFR part 58 and 21 CFR part 820• Responsible for overall scientific strategy and project management for Mirasol PRT System • Subject matter expert for laboratory safety, mammalian cell culture, pathogen reduction studies (viral, bacterial, parasite). Reviewed and approved scientific studies in these areas.• Participated in US FDA pre-submission meetings for a PMA medical device. Participation included helping with the overall scientific strategy in collaboration with the TBCT Regulatory team, preparing presentation materials, forming scientific rationales, and partaking in in-person discussions with the US FDA review team • Assisted TBCT regulatory team with ex-US regulatory compliance and submissions (MDD and MDR) • Helped form relationships with outside experts and key opinion leaders in the blood banking industry to further the scientific advancement of the Mirasol PRT System• Contributed to the overall campus wide laboratory safety program through active participation in cross-functional laboratory safety team• Promote the Mirasol PRT platform through the publication of key material in peer-reviewed journals -
Laboratory Scientist Ii / Lab LeadTerumo Blood And Cell Technologies Jan 2006 - Dec 2011• Active participation in regularly scheduled audits to help ensure compliance to GLP (21 CFR part 58)• Helped develop, write, and maintain laboratory standard operating procedures• Initiated, planned, and completed both internal and external studies designed to demonstrate the effectiveness of the Mirasol PRT System against blood borne pathogens of concern – GLP Study Director• Member of CAPA team, which was tasked with evaluating quality trends in product safety, employee training, and equipment variances• Set priorities for internal microbiology work• Off-site software upgrades, instrument installations, and customer training to the Mirasol PRT System -
Laboratory ScientistTerumo Blood And Cell Technologies Jan 2002 - Jan 2006• Evaluated and procured new bacterial and viral species• Developed and validated TCID50, plaque, and colony count assays to measure the effectiveness of the Mirasol PRT System• GLP study director• Initiated, planned and completed both internal research and GLP verification studies designed to measure the reduction of a variety of different pathogens when treated with the Mirasol PRT System -
Laboratory TechnicianTerumo Blood And Cell Technologies Mar 2000 - Feb 2001• Maintained multiple bacteria and mammalian cell cultures• Performed pathogen reduction studies utilizing a TCID50 assay to measure mammalian virus reduction and a plaque assay to measure bacteriophage reduction -
Laboratory TechnicianColorado Medtech \ Genprobe Jan 1999 - Jan 2000
Shawn Keil Education Details
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Molecular, Cellular, Developmental Biology -
Biochemistry -
Enviromental, Population, And Organismal Biology
Frequently Asked Questions about Shawn Keil
What company does Shawn Keil work for?
Shawn Keil works for Colorado School Of Mines
What is Shawn Keil's role at the current company?
Shawn Keil's current role is Laboratory Manager / Research Scientist.
What is Shawn Keil's email address?
Shawn Keil's email address is sk****@****nes.edu
What schools did Shawn Keil attend?
Shawn Keil attended University Of Colorado Boulder, University Of Colorado Boulder, University Of Colorado Boulder.
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