Chantel Edwards Email & Phone Number

• Reviews manufacturing requests, receives, and evaluates cellular therapy products for processing and testing• Aseptic processing in ISO5 laminar flow cabinets and ISO7 & ISO8 clean rooms• Obtains laboratory results and performs calculations as outlined in Protocol Specific Instruction (PSI)• Enters and acquires safety assay results including endotoxin, bacterial sterility, and gram stain as required for certificate of analysis • Manufactures cellular therapy products under FDA approved investigational new drug (IND) applications using cGMP• Cryopreserves cellular therapy products using control rate freezers before storage in liquid nitrogen tanks• Performs cell separation methods using Miltenyi CliniMACS and elutriation• Completes equipment maintenance, equipment calibration, and processes troubleshooting in a timely manner• Discovers resolutions to sudden occurrences during the testing or manufacturing process • Maintains chain of custody and product identity throughout manufacturing processes, utilizing clerical checks of all product labels• Assists in training new associates on laboratory protocols, methodology, and techniques• Aids in reviewing SOPs and creating work instructions• Effectively communicates issues in product testing with the potential to affect results to Assistant Supervisors and Supervisors• Carries out comparison studies testing new methods against existing methods

Gaithersburg, Maryland, United States

• Maintained suspension of HEK-293 cells for use in client productions• Executed transfection experiments with client plasmids to produce vector product• Used MACS Quant to perform flow cytometry on transfected cell cultures • Utilized FlowJo software to analyze flow cytometry data• Maintained adherent cell culture for transduction experiments • Assembled and operated single use stirred tank bioreactors from 2L to 50L working volume• Documentation of experiments• Received, stored, and documented client plasmids used in productions• Provided interdepartmental coverage to ensure internal projects are completed in a timely manner

Baltimore, Maryland, United States

• Performs microbiological testing procedures: autoclave verification using biological indicators, potable water and bioburden testing using Milliflex pump per Manufacturing/Quality Control batch records• Operates Lonza plate reader to carry out endotoxin testing on water and client product samples• Executes environmental monitoring of clean rooms and non-aseptic areas using SMA units for viable and Lasair III for non-viable air sampling• Completes routine cleaning and monitoring of biological safety cabinets• Conducts gram staining procedure on environmental isolates and analyzes results using light microscope• Reviews incubated media for growth and records data in logbooks • Obtained clean room gown certification• Collaborates with Project Manager and QA to provide microbiological expertise on project warp speed operation• Utilizes PharmNet and internal Excel software to format data generated from filling operations• Informs managers upon observing OOS, OOL, or generation of deviations• Practices Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures• Independently follows written and oral guidance working individually or in a team-oriented environment

Baltimore, Maryland Area

Lab Management• Supported the design and development of cell culture media and supplements• Designed experimental plans with guidance and executed experiments, analyzed data, generated laboratory protocols, and contributed to technical reports and product summaries• Prepared cell line specific media and supplements for stability and research projects• Implemented ordering system to acquire laboratory supplies in timely manner for experiments• Performed routine calibration and troubleshooting of laboratory equipment (ViCell, Osmometer, BioHT, pH meter, Victor, Octet, incubators, orbital shakers)• Maintained log of batch records for each reagent made• Managed internal procurement system (SupplyConnect) to place orders • Worked with regent and media suppliers, equipment sales representatives and instrument repair technicians to procure special consumables and equipment for experiments Experimental Skills• Completed cell banking using cryopreservation methods on adherent and suspension cell lines upon adaptation to specific media conditions• Carried out R&D stability testing using mammalian suspension cell lines (CHO 8757, 8108, GNE, 7862) in shaker flasks• Performed aseptic cell culture techniques in Biological Safety Cabinet using mammalian adherent cell lines (VERO, HEK-293, BHK)• Rotated through labs to work on diverse projects, prioritizing as needed based on guidance from senior staff and management• Trained new associates in aseptic cell culture techniques, procedures, and other basic laboratory procedures• Performed Mycoplasma testing using qPCR techniques (LightCycler 480)• Supported senior scientists with Ambr mini bioreactor, tabletop bioreactor, and fermenter studies• Maintained careful documentation of experimental procedures and data in laboratory notebook• Analyzed and presented data during team meetings• Obtained familiarity with ELISA, western blotting, protein purification, and transfection techniques under senior scientist guidance

Naples, Florida Area

Lab Management• Recorded temperatures for incubators and refrigerators twice daily and troubleshooted variances• Performed daily and weekly lab maintenance tasks: streak positive controls for pathogens (E. coli, Pseudomonas spp., S. aureus, Salmonella spp.), isopropyl working surfaces end of day, fungicide spray weekly• Received in customer samples, signed off chain of custody, and sent sample receipts• Adhered to laboratory ISO 17025 standards• Maintained laboratory supply inventory and placed orders as needed• Maintained paper and electronic records of customer chain of custody for one yearExperimental Skills• Prepared media, reagents, and materials as needed for laboratory testing (TSB, MRS agar, TSA, SDA) • Performed gluten testing on customer samples • Used light microscopy to identify and enumerate mold spores collected on sampling cassettes• Analyzed and recorded customer test results and drafted reports for lab manager approval• Performed Gram staining to differentiate gram-positive and gram-negative bacteria• Used AOAC and USP methodology to provide quotative and qualitative results for: E. coli, coliforms, Clostridium spp., Lactobacillus spp., Salmonella spp., S. aureus, Pseudomonas spp., Enterobacteriacea, Listeria, B. cepacia, Bile tolerant gram-negative bacteria• Performed tape lifts on fungal plate growth for identification of spores using light microscopy• Performed heterotrophic plate counts to enumerate heterotrophic bacteria from customer samples

Fort Myers, Florida Area

Opening and closing business officeAssisting customers with tag and title related questionsPreparing DMV documentsReviewing and processing documents associated with vehicle purchasesInteracting with sales teamTendering cash and debit transactionsPreparing bank depositsSetting goals for personal development

Fort Myers, Florida Area

Managing inventory and stocking productsBuilding strong external customer relationships by delivering exceptional customer serviceCreating strong internal customer relationships by performing inter-departmental dutiesEfficiently processed sale and return transactionsAid in training of new employeesAssessing customer needs to recommend relevant products

Master Of Science - Ms, Biotechnology

Bachelor Of Science (B.S.), Biology/Biological Sciences, General

High School Diploma, Information Technology