ELIZABETH CAWLEY, NCPT, PPN
Miramar, Florida ****3
**********@*****.***
SUMMARY
Over 6 years of Research and Development (R&D) experience in a FDA regulated biotechnology and medical device industry. Pre-concept development and characterization, preclinical development, wet laboratory, and mechanical properties testing. Worked independently or as part of a cross-functional team focused on timelines, budgets, in compliance with standard operating procedures (SOPs). Expanded responsibilities included: started a company wide mentoring program, project managed on a cross functional team for business excellence, R&D representative on the safety committee and first aid responder.
EXPERIENCE
LIFECELL CORPORATION, Branchburg, NJ
Assistant Scientist II (Process Analytics) January 2008 – August 2011
• Managed several projects simultaneously through the iterative development of the project life cycle; planning, design, product development, testing, analysis and presentation.
• Led design and implementation of animal studies, several in-vitro/in-vivo assays for current and new product evaluation.
• Presented data driven decisions that impacted technical strategy.
• Conducted analysis and evaluation of animal explants.
• Conducted method development and optimization of several in-vitro assays for new product testing.
• Authored protocols, clear communication and presentation of methodologies and data.
• Contributed data for the completion of milestones associated with company projects.
• Supported all KCI/LifeCell approved projects and perform standardized testing.
• Trained staff on technical method and instruments.
• Ensured compliance with GMP/GLP.
• Liaison between Research and Development and Production.
Assistant Scientist (Cryopreservation) October 2005 – January 2008
• Created new concepts with the purpose to transfer to product development.
• Modified and created new methods for evaluating concepts.
• Designed and executed planned experiments consistently in order to achieve timelines and goals.
• Executed and improved testing methods by identifying new tools and sources.
• Collected data and provided statistical analysis with a brief summary.
• Improved current methods of processing samples by making them more efficient and safely.
• Trouble-shoot technical problems and provided technical support off-site and non-functional tasks.
• Trained interns and temporary staff.
• Taught processing technicians how to procure material needed for testing.
• Set up, operated, and maintained laboratory instruments; monitored experiments, recorded results in a laboratory notebook, and presented conclusions to the core team.
• Handled and test samples in accordance with SOPs, IFU, GMP, QSR, GLP, FDA, RCRA, and OSHA.
OTHER EXPERIENCE
THE GLOBECON GROUP, LTD, New York, NY
Assistant Manager Design
• Negotiated rates with vendors cutting costs by 80%.
• Supervised a staff of three, trained freelance employees,
created training manual for departmental new hires and held weekly staff meeting.
• Successfully determined schedules to ensure deadlines were met.
• Spearheaded e-learning project and created interactive documents.
Senior Desktop/Electronic Publisher/Assistant Manager
• Created electronic versions of monthly publications.
• Managed and monitored vendor relationships with the objective of guaranteeing consistency and high quality, while maintaining an emphasis on cost-containment.
• Enhanced internal communication through the development of an electronic tracking system.
• Created macros, templates and financial graphics to maintain uniformity of hard and electronic material.
Senior Desktop Publisher
• Developed and implemented tracking system of financial educational material in house and with venders.
• Researched and retrieved financial data from Reuters and Bloomberg.
• Incorporated color in to graphics.
• Devised a coding system for financial educational material
• Created and maintained electronic archival database.
• Designed, created, layout, format, and proofread text and graphics.
EDUCATION
Touro College, NY, NY Major: Biology Minor: Psychology, BA 2005
Raritan Bay Medical Center, Old Bridge, NJ Emergency Medical Technician Program
Scheduled to take State and National Certification Exam for EMT
160 hours included the following courses: EMT-B, CPR and Hazardous Material Awareness
Enadex Medical Institutes, Inc., Elizabeth, NJ National Certificated Phlebotomist, 315*-****-**
Phlebotomy curriculum included the following courses: Interpersonal Relations, Anatomy and Physiology, Circulatory system, Medical Terminology, Legal Aspects of Allied Health, Clinical Office Procedures, Practical Hospital Applications, Aseptic Medical Technique, Laboratory Specimen Collection and Hematology
Electrocardiography curriculum included the following courses: Cardio and Pathophysiology, Lead placement Techniques and evolving comprehension of EKG.
State University College of New York at Buffalo, Buffalo, NY, Major: Biology, Minor: Art History
VOLUNTEER AND OTHER EXPERIENCE
Community Empowerment Center of Washington Park (Food Pantry), Hollywood, Florida, August 2015 - Present
Home School Teacher, Parlin, New Jersey, September 2011 - June 2015
Full Time Care Giver, Parlin, New Jersey, August 2011 - November 2014
Morgan Station First Aid Rescue Squad, Crew, Morgan, New Jersey
Performed all basic life support procedures
Certified in CPR, AED and Standard First Aid, American Red Cross and American Heart Association
Robert Wood Johnson Hospital, Physician Shadow, Endocrinologist, New Brunswick, NJ
Observed the dynamics of physician/patient relationship and procedure during clinical visitations
Observation included: obtain medical history, physical assessment, diagnosis, treatment plan, medical terminology and HIPPA policy. Interfaced with staff and patients.
Methodist Hospital, Emergency Room and Blood Bank, Brooklyn, NY
Biotechnology, Regenerative Medicine, Tissue Engineering, Procurement of Human Tissue and Porcine, Biomedical, Medical Devices, Life Sciences, Validation, Assay Development, Cell Biology, Western Blotting, Aseptic Technique, SOP, Immunohistochemistry, Mechanical Testing, MiniTab, MS Word, Excel, PowerPoint, Oracle, TrackWise, WorkDay, First Aid, Safety Committee, Mentor, Autoclave, Suturing, Mechanical Testing, Histotechnology, Protein Assays, DNA, Sterilization, Spectrofluorometeric, Microplate Reader, pH Meter, Refractometer, Ultrasonic Cleaner, Clean Room, Sterile Gowning, Motorized and Manual Zimmer, Brennen and SLR Meshers, AATB Accredited
Cryobiology / Biostability: Cryopreservation, Vitrification, Lyophilization (Freeze-drying), Anhydropreservation, Protective Solutions, Biobanking, Biorepository
Analytical Techniques / Instruments: Differential Scanning Calorimetry (DSC) / TGA, ELISA, Flow Cytometry (FACS), Instron, Phase & Fluorescence Microscopy
Biomaterials / Tissue Engineering: Absorbable Polymers, Bioscaffolds, Collagen, Decellularized Tissues and Organs, Extracellular Matrix, Implantable and Bio-surgical devices
Regulatory Practices: GLP, cGMP / QSRs, ISO13485, biocompatibility (ISO 10993), pre-clinical studies, 510K, design control