Manufacturing Maintenance
Resume:
Stephanie Wimberly
*********.***********@*****.***
** ***** **** *****, *********, GA 30014
Purpose:
Skilled at learning new concepts quickly, working well under pressure, communicating ideas clearly and effectively. I am a demonstrated achiever with exceptional knowledge of: supervisory, leadership of production schedule attainment, medical research knowledge and experience, process engineering, and biopharmaceutical manufacturing.
Career History and Accomplishments:
Shire 09/2015 to Present
Lead Manufacturing Associate III for Albumin Purification
Duties Consisted of:
Act as supervisor when supervisor is not present
Executing CQV activities
Running Engineering processes
Maintaining training requirements
Writing and Revising SOP’s, Job Aids, JHA’s
Prepare buffer solutions
Operate Clean-in-Place (CIP) and Clean-out of-Place (COP) systems
Assemble and operate filtration systems
Operate general production equipment (such as pH and conductivity meters, autoclaves, autotitrators, refractometers, turbidity meters, integrity testers, and portable mixers, etc)
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
Write, revise and review pertinent documentation as applicable
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
Dendreon (Contracting through Radiant) 11/2014 to 04/2015
Aseptic Manufacturing Associate
Duties Consisted of:
Checking kitted materials to make sure the correct ingredients, batch records, and COI are correct
Utilized Good Manufacturing Practices in an aseptic environment and documents events and information according to batch record, SOP, and FDA guidelines.
Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
Processed patient autologous blood to make Provenge.
AEROTEK (contracting through GSK - GlaxoSmithKline) 01/2014 to 09/2014
Biopharmaceutical manufacturing technician
Duties Consisted of:
Prepares for production by reviewing production schedule; studying and clarifying specifications; calculating requirements; assembling and weighing materials and supplies.
Prepares equipment by performing sterile cleaning-in-place (CIP),
Steam-in-place (SIP), and cleaning out-of-place (COP); conducting operator inspections; performing preventive maintenance checks
Produces requirements by operating and monitoring equipment; observing varying conditions; adjusting equipment controls; calculating concentrations, dilutions, and yields; adhering to aseptic filtering and filing procedures.
Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
Documents production by completing forms, reports, logs, and records of equipment and batches.
Updates job knowledge by participating in training opportunities.
Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
Vast knowledge and comprehension of SOP’s (Standard Operating Procedure)
Standardizations of pH meters, Bench top scales, Osmometers, conductivity meters.
Operational experience in utilizing DeltaV OIT (Operational Interface System)
Experience in connecting transfer panels, and installing bleed valves.
Knowledge and utilization of CIP, SIP and Rinse of prep and hold tanks.
Experience in mixing buffer and media products on a large scale grade.
Student Researcher- Experimental Parasitological Class at Howard University in Washington, D.C.
09/2011 to 12/07/2012
Duties consisted of:
Analyzing and comparing antigen profiles of Leishmania donovani and Trypanosoma lewisi
Analyzing the different bands and their molecular weight, to observe if there are similar bands (protein) to conclude further implications.
Executing and running laboratory techniques such as: PCR, gel electrophoresis, ELISA, and Western Blot.
Student Researcher- K-IMBRE SUROP Program at K-State University in
Manhattan, Kansas 05/25/2008 to 07/30/2008
Duties consisted of:
growing and culturing MCF10a Human mammary
growing and culturing epithelia cells in amphotericin B medium and cholera toxin medium
Executing different research experiments
Executing and running laboratory techniques such as: PCR, gel electrophoresis, and Ussing chamber.
Concluding and presenting the final experimental goal: separate blood from milk, so as to administer pharmaceutical postpartum drugs to breast feeding mothers without tainting the breast milk consumed by the baby.
Student Researcher- Dr. Abraham’s Laboratory in Langston University,
Langston, OK
01/2008 to 05/2008
Duties consisted of:
Processing with Azoreductase and Micrococcus luteus.
Executing laboratory techniques such as: running PCR, electrophoresis, and culturing bacterial cells, making media and agar, and monitoring laboratory inventory
Entering, writing, and presenting research data
Education:
B.S. Major in Biology, 2013
Howard University, Washington, D.C.
M.S. Major in Complementary and Alternative Health, 2017
American College of Health and Sciences
5005 SW Macadam Ave, Portland, OR 97239
Goal:
My purpose is to find a cure or preventative pathway that will impede the inflammation process; for which majority of diseases and disorders arise.
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