Development Specialist
Resume:
Nadege Jean
Medford MA, *****
Phone: 617-***-****
Email: **********@*****.***
Objective To obtain a permanent position in Regulatory Affairs that will use my current experience in the pharmaceutical industry
Professional
Summary
Goal-oriented biotechnology professional with 5+ years of experience. I have a track record of consistently meeting and exceeding established departmental goals and objectives. Skilled in building long-term relationships with all levels of biotechnology staff. Motivated and ambitious with excellent interpersonal communication, relationship management, and presentation skills.
Education
2009-Present Northeastern University Boston, MA
Masters in Regulatory Affairs for Drugs Biologics and Devices
2002-2005 Boston University Boston, MA
Bachelor of Science in Biomedical Laboratory and Clinical Science
2002-2004 Boston University Boston, MA
Certificate in Clinical Research
Skills
● Laboratory audits, batch records development/review
● Excellent organizational skills
● Working experience in GMP, GLP and GCP settings
● Cell Culture and aseptic technique skills
● Excellent communication skills
● Excellent interpersonal skills
● Ability to work independently and as part of a of team
Work Experience
2007-Present Shire Pharmaceutical Cambridge, MA
Development Specialist
Job Responsibilities:
● Author and revise batch records (BR)
● Revise and update SOPs
● Ensure compliance with all batch records and SOPs
● Maintain control of GMP training records and training files
● Train staff on appropriate batch records and SOPs
● Initiate CAPA, Deviations and change control Using Trackwise
● Training experience with Traincaster
● Participate in QA Audit, and inspections
● Act as primary contact between QA and cell banking group
● Develop master and working cell bank under cGMP guidelines
● Participate in Shire HGT training
● Responsible for adhering to domestic GMP regulations, cGMP's company policies
● Coordinate cell banking processes
● Perform production run data analysis
● Maintain growth of mammalian cell lines
● Adhere to department goals, and priorities
● Support other development groups workload, as needed
2005-2007 Bioprocessors Corp Woburn, MA
Research Associate
Job Responsibilities:
● Lead and managed multiple experiments for outside customers
● Wrote and reviewed SOPs as assigned
● Reviewed SOPs and participated in their release process
● Interacted with clients during audits and project troubleshooting
● Planned, coordinated, and executed experiments independently and
as part of a group
● Collected data, calculated, & reported on performance metrics
● Performed technology transfer, transient transfection,
media optimization following SOPs
● Designed experimental cell growth by optical density
● Designed experimental pH, metabolites and dissolved oxygen
● Maintained the growth of mammalian cell line
2005-2005 Beth Israel Deaconess Medical Center Boston, MA
Clinical Research Assistant
Job Responsibilities:
● Created Case report Forms (CRFs) for new research protocols
● Reviewed CRFs and informed consent documents under GCP
Guidelines
● Utilized paper CRF and worked with site personnel to resolve
Queries
● Complied with Regulations by following the hospital procedures
to ensure compliance with FDA, and GCP
● Coordinated documentation by working with the other members to assure that all
critical documentation pertaining to clinical trials is tracked, and filed
according to Standard Operating Procedures (SOPs)
● Managed site master files contents and data entry
● Developed inclusion/Exclusion criteria flow charts for new study
● Wrote and revised SOPs
● Preparing IRB documents
2003-2005 Dyax Corp. Cambridge, MA
Research Assistant
Job Responsibilities:
● Performed transient transfection using different type of vessels
under GLP guidelines
● Collaborated on projects involving ELISA assay, PCR
gel electrophoresis, western blot, PCR, DNA purification
● Maintained the growth, freezing, and splitting of mammalian cell
Lines
● Scaled up cell culture for protein expression
● Prepared media nutrients and followed all types of SOPs
Computer skills
Microsoft Excel, PowerPoint, and Word.
Languages
English, French, Creole
Author Evaluation of SimCell high throughput technology for cell culture process development Poster presented at ESACT, Dresden, Germany, June 17-20,2007.
A. Amanullah, J.M. Otero, M. Mikola, A. Hsu, J. Zhang, Merck & Co. Inc., Rahway, NJ/USA; J. Aunins, Merck & Co. Inc., West Point, PA/USA; P. Russo, J. Voruganti, N. Jean, M. Stebulis, B. Schreyer, S. Tingley, J. Hope.
References Available upon request.
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