Nicola Denis
Parsippany
Summary
Passionate Scientist seeking to obtain a challenging and rewarding position in Clinical Operations that will allow me to utilize my skills in essential data analysis, document management, Protocol generation, review and revise SOPs, technical writing which include written deviations and OOS (out of specification) investigation. Thrives as a team player to find solutions to challenging problems. Organized and dependable candidate successful at managing multiple priorities with strict deadlines. Highly self-motivated with extensive R&D experience and fantastic work ethic.
Overview
25
25
years of professional experience
Work History
Scientist
Edgewell Personal Care Corp
02.2021 - Current
- Review stability regulatory documents, and prepare forms for generating stability report
- Manages and Maintains all stability-related documentation, i.e., stability reports, rationales, OOS’s, excursions, written deviations, third party data, and Stability SharePoint website (LIMS).
- Maintain and archive sample tracking and chain of custody records in accordance with GLP/GMP requirements.
- Updating and maintaining internal databases, and the stability tracking system
- Analyzes, summarizes, and report trends of stability data and investigates unexpected results
- Assist in managing the stability program, review data and evaluate trends for internally and externally developed products, contract laboratories, and external partners.
- Review documentation to be included in regulatory submissions (batch records, specifications, methods, and stability data)
- Maintain regulatory tracking databases, update SOPs and route documents for signature
- Assist in the revision of internal SOP’s
- Help to nsure program compliance with applicable regulations, international guidelines, cGMP and cGLP requirements, as well as occupational and environmental safety guidelines.
- Shipping and tracking study documents and protocol to offsite vendors
Associate Scientist
Edgewell Personal Care
02.2014 - 02.2021
- Initiate and monitor FD&CA regulated stability studies by ensuring that all samples are placed and pulled at appropriate time points following internal SOP’s, company procedures, GMP, GLP, and GDP guidelines.
- Ensure that testing labs receive chain of custody at the time of sample delivery.
- Monitors chamber performance.
- Maintaining stability electronic database, spreadsheets, logbook and archives
- Ensure that expired samples are stored in satellite waste area according to written procedures
Associate Scientist
Johnson & Johnson
07.2013 - 10.2013
- Heavy involvement in launch projects from marketing concept to pilot and production
- Conduct Oral Care Literature review
- Identify raw materials and technologies suitable for product development
- Manage and coordinate R&D projects
- Perform product stability on all formulas as well as rectify stability issues.
- Consult with chemical manufacturers and distributors to evaluate and source raw materials and new technologies
- Accurate notebook recording, data collection and making changes to current SOP’s for R&D laboratory to maintain cGMP compliance and good working practices.
- Carefully following safety standards and lab regulations in a GMP environment
Associate Chemist
L'Oreal
05.2009 - 06.2013
- Complete product development projects on a timely basis
- Knowledge of cosmetic/personal care raw materials, functionality, and interactions
- Identify new/improved formulation technologies, raw materials and implement them to meet project needs
- Proactively scan and research new marketing concepts and raw materials
- Monitor the quality and conformity of formulas
- Maintain and upgrade SOP documentation and keep accurate batch recording
- Prepare and submit documents for analytical, micro, and safety testing
- Trouble shouting and stability monitoring of products
- Interact with marketing personnel to aid in developing strategic marketing directives in enhancement product
- Knowledge of Global Cosmetic Regulations
- Knowledge and understanding for formulations/emulsions, and raw materials
- Analyzed organic and inorganic compounds to determine chemical and physical properties of each.
- Maintained current and running inventory of all materials and ordered new stock to replenish supplies.
- Stayed current with industry trends through regular attendance at professional workshops, seminars, and conferences.
Professional Development
01.2005 - 05.2009
Went to University of Antigua College of Medicine. Medical School in the Caribbean
Jr. Chemist
COTY Inc., R&D
09.2002 - 12.2004
- Collaborate with internal employees to develop new foundation, and improve upon existing product line
- Responsible for color matching, in depth troubleshooting and contributing to new product innovation
- Communicate development challenges to management on a timely basis
- Accurate note book recording, and data collection
- Prepare reports on stability findings
- Ability to manage multiple projects at once
Clinical Trial Assistant (Field Work Project)
University Hospital
01.2004 - 05.2004
- Work closely with the Site Start UP (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation.
- Log and prepares study materials prior to study initiation
- Assembles study files, paperwork, regulatory binders, schedules, etc.
- Work with study monitors in all aspects of the study (e.g. IRB completion, data collection and correction)
- Maintain Clinical Trial files and documentation ( Form FDA 1572 documentation, Informed Consent Form)
- Assist site with Investigational Review Board (IRB) submissions
- Close out study files once complete and file final reports
- Track QC documents for review and signature
- Maintaining records of all archived documents including consent and location of boxes
- Collect and tract patient enrollment information and update study management reports necessary.
- Basic administrative task such as copying, scanning, and filing of clinical documents
- Called subjects to remind them about follow-up appointment or for missing information
- Basic Knowledge of ICH-GCP and FDA regulatory guidelines.
- Followed HIPAA privacy Rules
Laboratory Technician
Merck Pharmaceuticals
09.2000 - 09.2002
- Robotic transfer of dry compounds into pre-weighed vials for shipment
- Weighed, labeled and ship compounds
- Updated and maintained sample inventory
- Operated basic laboratory equipment such as balances, pH meter, and pipette
- Maintain accurate lab records of all raw material in stock
Laboratory Technician
L'Oreal UAS
06.1999 - 09.2000
- Prepared samples for shipment on a timely basis
- Filled products for consumer testing
- Labeled product accurately
Education
Master of Science - Public Health- Epidemiology
UMDNJ School Of Public Health
Newark, NJ05.2004
Bachelor of Arts - Biology
Rutgers The State University of New Jersey, Newark
Newark, NJ05.1999
Skills
- Laboratory techniques
- Research and experiments
- Safety processes and procedures
- Assay development
- Microsoft Words
- EXCEL
- Power Point
- SAP
- LIMS
- Office Out look
- Rees Scientific Monitoring System
- Share Point
Timeline
Scientist
Edgewell Personal Care Corp
02.2021 - Current
Associate Scientist
Edgewell Personal Care
02.2014 - 02.2021
Associate Scientist
Johnson & Johnson
07.2013 - 10.2013
Associate Chemist
L'Oreal
05.2009 - 06.2013
Professional Development
01.2005 - 05.2009
Clinical Trial Assistant (Field Work Project)
University Hospital
01.2004 - 05.2004
Jr. Chemist
COTY Inc., R&D
09.2002 - 12.2004
Laboratory Technician
Merck Pharmaceuticals
09.2000 - 09.2002
Laboratory Technician
L'Oreal UAS
06.1999 - 09.2000
Master of Science - Public Health- Epidemiology
UMDNJ School Of Public Health
Bachelor of Arts - Biology
Rutgers The State University of New Jersey, Newark
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