Clarence Lyles, IV
Biopharmaceutical Process Engineering Intern at Jefferson Institute for Bioprocessing- Claim this Profile
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Bio
Experience
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Jefferson Institute for Bioprocessing
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United States
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Biotechnology Research
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1 - 100 Employee
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Biopharmaceutical Process Engineering Intern
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Jan 2023 - Aug 2023
Philadelphia, Pennsylvania, United States Optimization of Cryopreservation Freeze Profile for Mesenchymal Stem Cell Therapy •Analyze the effect of using different cryopreserving storage vials •Wrote & Executed Standard Operating Procedure for the 10 variable freeze profile experiment •Analyzed the effects of freezing vials at various rates •Lead Operation of Via Freeze Controlled Rate Freezer, Controlled Rate freezer, cryopreservation doers, Liquid Nitrogen doers, Flow Chromatography, thermocouples, etc. •Document all… Show more Optimization of Cryopreservation Freeze Profile for Mesenchymal Stem Cell Therapy •Analyze the effect of using different cryopreserving storage vials •Wrote & Executed Standard Operating Procedure for the 10 variable freeze profile experiment •Analyzed the effects of freezing vials at various rates •Lead Operation of Via Freeze Controlled Rate Freezer, Controlled Rate freezer, cryopreservation doers, Liquid Nitrogen doers, Flow Chromatography, thermocouples, etc. •Document all experimental procedures, sample collections, and experimental results •Track and Manage laboratory inventory •Manage lab equipment maintenance operations •Prepare media, reagents, and other materials for experiments and daily maintenance of the cells •Use of JMP software for Data Analysis and Experimental Design •Management and Supervision of interns up to group sizes of 15 people •Collaborate with team members, supervisors, and members of other support departments to assure prompt resolution of production issues •Oversee and train research scientists with techniques induing tissue culture, micropropagation, centrifugation, cryopreservation germination trails, media optimization documentation, and maintenance of lab equipment. •Provide routine formal presentations providing reports on the manufacturing process robustness, data analysis, risk assessments, and budget/timeline of the experimental process •Revise and/or Improve manufacturing processes to further optimized the cryopreservation profile Optimization of Rituximab using a Chinese Hamster Mice Cell Line •Trouble Shooting of operational inoculation, seed train, upstream, and downstream processes to increase production titer from 0.4 grams per liter to 1.0 grams per liter •Media preparation and Optimization of Media to promote proliferation of cells •Facilitated the operations of beach top scale Bioreactor •Use of 2 Step chromatography process (Protein A, and High Performance Liquid Chromatography) Show less
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LucasPye BIO
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United States
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Biotechnology
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1 - 100 Employee
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Bioprocess Associate I (Seasonal)
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May 2020 - Jan 2023
Philadelphia, Pennsylvania, United States Performed Production and Quality Control functions to include reviewing logbooks, forms, and records for completeness and proper documentation; ensured 100% compliance per FDA’s cGDP Requirements for Biologic Drugs Ensured 100% compliance with Bioprocess Standard Operating Procedures (SOPs) & Bioprocess Batch Records Participated in Bioprocess Risk Assessments & Change Control Project Design Performed calibrations, standardizations, and troubleshooting of in-process… Show more Performed Production and Quality Control functions to include reviewing logbooks, forms, and records for completeness and proper documentation; ensured 100% compliance per FDA’s cGDP Requirements for Biologic Drugs Ensured 100% compliance with Bioprocess Standard Operating Procedures (SOPs) & Bioprocess Batch Records Participated in Bioprocess Risk Assessments & Change Control Project Design Performed calibrations, standardizations, and troubleshooting of in-process equipment to include: pH meter, Osmometer, Turbidity meter, bench top scales, and floor scales; performed in-process measurements Performed filter installation, flushing, and integrity testing, bio-welds, and bio-seals; ensured 100% compliance with all current Good Manufacturing Practices, Good Documentation Practices, standard operating procedures (SOPs), and Food and Drug Administration regulations Performed Laboratory Bench-Top Techniques – including RNA isolations, DNA preparation, PCR/RT-PCR, gel electrophoresis, bacteria culture, computer gene analysis, restriction enzymes assays, plasmid isolation, Flow Cytometry, Elisa assays, cell culture, cDNA cloning, Aseptic technique, Microarrays, HPLC and other various laboratory techniques Performed transfers from media preparation tanks and carboys to bioreactors, harvest tanks, and single use biotech bags and bottles to support biologically active environments through either direct tank to tank transfer or transfers using portable pumps Documented routine inventories and cycle counts of high-value / routine-use consumable items, i.e. raw materials and single-use bioprocess equipment Show less
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Xavier University
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United States
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Higher Education
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700 & Above Employee
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Resident Assistant
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Aug 2018 - May 2020
Cincinnati, Ohio, United States
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Forniss Optometric
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United States
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Broadcast Media Production and Distribution
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1 - 100 Employee
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Physician Assistant
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Jun 2017 - May 2020
Indianapolis, Indiana, United States Managed office operations and provided operational support to ensure timely task completion - including: - Billing insurance - Maintaining office records in a secure system - Greeting and checking-in patients - including collecting their personal, medical, and insurance information while maintaining patient confidentiality per HIPAA
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Summer Job Shadow
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Jul 2017 - Jul 2017
Indianapolis, Indiana, United States - Observed doctor-patient interactions under the care of Dr. Clark J. Simons, M.D. - Observed surgical procedures - including a gallbladder removal and two hernia removals
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Job Shadowing
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Jun 2016 - Jul 2016
Indianapolis, Indiana, United States Observed LASIK Eye surgical procedures performed by Dr. Anthony J. Lombardo, M.D, Ph.D.
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Center for Pain Management
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United States
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Medical Practices
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1 - 100 Employee
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Summer Internship
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Jun 2016 - Jul 2016
Indianapolis, Indiana, United States Worked alongside Dr. Jocelyn Bush, MD Observed diagnostics and interventional medical procedures for pain treatment - including - Neuromodulation (spinal cord stimulators) - Intrathecal pump implants - Nerve blocks and injections
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Education
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Thomas Jefferson University
Master's degree, Biopharmaceutical Process Engineering -
Temple University
Certificate, Advanced Core in Health Sciences -
Xavier University
Bachelor of Science - BS, Biomedical Sciences, General -
Brebeuf Jesuit Preparatory School
High School Diploma, General Studies