Stael Dumesle has over 7 years of experience in quality assurance and project management for scientific research and medical device development. She has expertise in areas such as quality control, process validation, compliance with FDA regulations, and statistical analysis. She holds a Master's degree in Pharmaceutical Systems Management and Bachelor's degrees in Biology.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
The CMC Journey in the Regulation of Biologicsenarke
Journey in the Development of Biologics Through End of Phase 3
Our Goals
To better understand the FDA’s CMC requirements and expectations for biologic manufacturing and product testing
To better visualize a cost-effective, risk-managed approach to manage these manufacturing processes and products through clinical development into market approval
To better appreciate the challenges involved with controlling safety, potency, and impurity profiles for these products
Journey in the Development of Biologics Through End of Phase 3
Our Goals
To better understand the FDA’s CMC requirements and expectations for biologic manufacturing and product testing
To better visualize a cost-effective, risk-managed approach to manage these manufacturing processes and products through clinical development into market approval
To better appreciate the challenges involved with controlling safety, potency, and impurity profiles for these products
Similar to resume-stael-dumesle - SD - update (20)
1. STAEL DUMESLE
868 S. 20th
St. Newark, NJ 07108 973.704.0039 stael77@gmail.com
SUMMARY
Analytical, quality-focused engineer with extensive experience directing and enhancing complex scientific projects
against aggressive metrics. Diverse research experience includes cell culture, SDS-PAGE gel electrophoresis, gas
chromatography, aseptic technique, and high-pressure liquid chromatography. Articulate communicator skilled in
resolving customer complaints and working across teams to drive full cross-functional collaboration. Academic
background in drug and product development, Total Quality Management.
Areas of Expertise:
Scientific Research • Project Management • Quality Assurance • Strategic Planning • Laboratory Processes
Product & Process Validation • Raw Materials Management • Performance Specification Modeling
CGMP/ISO/CFR/FDA Regulations • Compliance • Root-Cause Analysis • Inventory Control • Reporting • JD Edwards
•Statistical of variance (ANOVA) • Design of Experiment (DOE) •Microbiology: Aseptic Techniques, Gram Staining •
Biochemistry: HPLC, GC, SDS-PAGE
EDUCATION
MS, Pharmaceutical Systems Management (Anticipated 2015), New Jersey Institute of Technology
BS, Biology, 2007, Montclair State University
AS, Biology, 2004, Essex County College, Newark, NJ
• Served as lab assistant at the Biochemistry lab, providing quality support, lab preparation and equipment
sterilization
PROFESSIONAL EXPERIENCE
INTERNATIONAL TECHNIDYNE CORP. Edison, NJ
QC Analyst II September 2011 – Dec 2014
• Plan and direct high-priority projects in line with all requirements and technical review team
requirements
• Collaborate heavily with R&D, Clinical Affairs, and Quality Engineering to define and assess project scopes
• Guide and mentor quality control personnel on lab processes, equipment maintenance, and systematic
errors
• Perform QC inspection on medical devices as per the Standard operating Procedures (SOP’s)
• Conduct pre-inspection internal audits to assess areas of regulatory risk in preparation for
inspections/audits by FDA or ISO
• Provide thorough, timely and accurate responses to customer complaints
• Work with various functional groups to investigate, resolve, and relocate non-conforming material with
known performance issues,Knowledge and application of Six Sigma ,ANSI/ASQ Z1.4 Sampling Plan and
Statistical Analysis
• Performing investigations related to product complaints and non conforming events to ensure compliance
to FDA and other worldwide health authority cGMP regulations and guideline, site SOP’s and industry
standards
• Presents product complaint information or non- conforming events,independently, to in house client staff
and if appropriate, to to the responsible individuals at service providers
• Assists with the review of internal and external SOP’s as related to investigations
• Maintains quality documentation files, databases and logs
• Tracks metrics and trends as well as compliance issues and their resolution on a periodic basis
• Participates in determination of and recommends Corrective And Preventive Action of investigations and
reviews implementation of corrective and preventive actions
Key Contributions
• Improved assay development methodology through initiation and development of test validation ( IQ,OQ,PQ)
• Assessed and mitigated project risk via utilization of Engineering Change Order (ECO) and CAPA from initiation
to certified review Board (CRB) approval
2. • Initiated corrective actions to address deviations in standard operating procedures
• Trained current and new employees in Compliance to 21 CFR part 820 , 21 CFR 210,21 CFR 211,21 CFR 11, 21
CFR 58, ISO 13486 and FDA regulation
QC Technologist I Nov. 2007 – Sep. 2011
• Tested biological raw materials and finished goods in preparation for product release
• Tested currently available products for process validation to support established quality objectives
• Conducted extensive investigative testing of non-conforming materials and designated appropriate relocation
• Delivered extensive training for new hires related to finished product processes for SOP compliance
• Prepared detailed test result documentation/reports and maintained complex product release records
Key Contributions
• Implemented lean inventory supply management system with safety stock in order to ensure optimal levels of
material availability
• Achieved biomedical device standardization through utilization of cGMP and FDA expertise
AFFILIATIONS & COMMUNITY
Volunteer, Essex County College Student Center and University of Medicine and Dentistry-New Jersey Recovery Room