Kelly Fields
***** ******** **** ** *********, MD 21758 240-***-**** ***********@*****.***
PROFILE: Highly qualified professional with over 7 years of experience in Upstream and Downstream processing for biological GMP facilities involved in the purification of biological products including but not limited to protein, antibody and viral vectors; eager for professional growth opportunities.
Buzz words: SOP, validations, documentations, cross-functional teams, supervising, proficiency in manufacturing execution systems,
PROFESSIONAL EXPERIENCE
Manufacturing Technician I, II & III
Astra Zeneca, Frederick, MD June 2018 – March 2023
Proven ability to perform all process steps of upstream and downstream production operations.
Execution of GMP protocols as required as well as the ability to execute projects with minimal instruction and strategic direction.
Complete acquaintance with and understanding of the general and detailed aspects of the job, and their practical applications to problems and situations commonly encountered.
Advanced knowledge of cGMP standards and equipment to perform first line trouble shooting
Root cause analysis (RCA), Deviations, Documentations (GDP)
Ability to generate SOPs, MPRs, and SPRs for equipment and procedures used in the manufacture of biological based products
Ability to deal with problems involving a few concrete variables in standardized situations while performing under limited supervision and no instructions for routine work. * Good organizational skills. Familiarity and proficiency in SAP, PAS-X, HMI. SABA. * Certified trainer for equipment and processes used in Downstream and Upstream applications. Lead technician for area working in and experience on day and night shift.
Achievements:
Certified trainer of technicians on --- act as the primary trainer of those with less experience (and may act as interim Lead as required
Sr. Lab Technician May 2017 – June 2018
EcoLab, Martinsburg, WV
Sr. Lab Technician
Laboratory testing of products (raws, line starts, end of runs, batches, tankers, in line mixes etc.)
Calibrations and MAs of all laboratory analytical equipment
Titrations (manual and autotitrators), densitometer (specific gravity), pH meter, Minolta, viscometry, chloride testing, refractive index (Brix) testing
HPLC testing and analysis
Lab Technician September 2016 – May 2017
Shepherd Unviersity, Shepherdstown, WV
Solution, Reagent and Plate preparations, Autoclaving, Equipment Calibrations
Preparation and set up for science labs and clean up of science labs and glassware
Maintenance of stockrooms, ordering, delivering and inventorying chemicals and supplies
Supervision of undergraduate student assistants and authorized students in robotics laboratories
Work with faculty to assist in the maintenance and/or repair of laboratory equipment
Field Reviewer January 2013 – January 2016 Outcomes Health Information Solutions, Alpharetta, GA
Accurately and efficiently conduct medical record review services
Travel to medical facilities in specified area of region from home to complete review services
Projects: HEDIS, PIA
Scan relevant components of the medical record to support reviews performed and upload scanned medical records daily
Communicate effectively and professionally with care provider offices, clinics, hospitals, other clinical facilities
Abide by all HIPAA and associated patient confidentiality requirements
Intern, TAC1 USDA project January 2013 – May 2013 InnovaBio, Hagerstown, MD
Isolation of the TAC1 gene from peach trees. To be used for its "pillar effect" on tree growth. To be used to express trait in plum trees.
Attained through the following steps: PCR Amplification, Agarose Gel Electrophoresis confirmations, TOPO TA Cloning, TSA/Kanamycin/IPTG/X-Gal plating, Bacterial DNA Preps, Restriction Double Digestion, MIDI Preps, Construct Sequencing (outsourced) & Gel Purification
Charge RN January 1998 – December 2008 Reeder's Memorial Home, Boonsboro, MD
Assessment and care of resident's medication and treatment
Acted as liaison between physicians, family and residents
Managed and delegated responsibilities to nurses and nursing assistants
Compiled audits on specific medication administration
EDUCATION
Shepherd University, Shepherdstown, WV
Bachelor of Sciences: Biology, Minor: Chemistry
Hagerstown Community College, Hagerstown, MD
Associate of Sciences: Major: Biotechnology
Frederick Community College, Frederick, MD
Associate of Sciences: Major: Nursing
Computer Skills: Microsoft Office, SAP, PAS-X, HMI. SABA
OTHER INTEREST
References can be provided upon request.
Detailed References
Mary Carnes, Production Lead
Astra Zeneca
633 Research Drive
Frederick, MD
****.******@***********.***
Michael Smith, Production Lead
Astra Zeneca
633 Research Drive
Frederick, MD
*******.*******@***********.***
David Wing, Department Chair, Biology
Department Chair, Biology, Shepherd, University
Shepherdstown, WV
*****@********.***
Carol Plautz, Associate Professor, Biology
Shepherdstown, WV
*******@********.***
Cindy Dove, Professor
11400 Robinwood Drive
Hagerstown, MD 21742
******@************.***