PIERRE J. LEVASSEUR, Ph.D.
42 High Street Newburyport, MA 01950
(978) 255-1765 / (617) 462-5201 (mobile)
pjlev@aol.com / plevasseur@comcast.net
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OBJECTIVE
Seeking to benefit a company with my vast knowledge of product development, and as a senior level scientist
experienced in project management and quality assurance, contribute to directing the design, development,
evaluation, verification, validation, transfer and launch of regulated medical devices.
EXPERTISE
Project Execution
Seasoned planner and executor of projects. Proficient in assessing technology and design needs,
defining and scheduling tasks, meeting challenges, executing on deliverables, hitting timelines.
Skilled in team planning and negotiating to achieve milestones. Delivery of project status
presentations. Multidisciplinary and international team experience.
Product Development Disciplined in product development. Experience in and knowledge of product phases from
concept to design, feasibility, development, verification, validation, transfer and launch. Defined
product specifications. Led process validation and product evaluation trials. Promoted products.
Assay Design
Experienced in assay design and development. Practical hands-on approach to product design,
platform, disposable and reagent development, product transfer and technical solutions.
Established procedures for sample handling and processing, parameters for reagent formulation
and conjugation chemistry, protocols for surface coating and detection assays, approaches to
instrument design and programming, methods for data analysis and reporting, and quality control
procedures for incoming materials, in-process manufacturing and product release.
Technical Expertise
Expertise in molecular diagnostics, immuno-diagnostics, genetic profiling, microRNA research,
qualitative / quantitative assays, amplification technologies, assay platforms, analytical molecular
techniques, experiment design (DOE), image analysis, data analysis, statistical analysis (JMP).
Technical Support
Educator of coworkers and customers in understanding and applying advanced technologies.
Realized procedures, protocols, experimental strategies, data analysis methods, custom products.
Quality Assurance
Versed in document control, design control, risk management. Subject matter expert in product
design and testing. Advisor to study protocols, validation and verification protocols, technical
reports, technical reviews, design reviews. FMEA facilitator. 21CFR820, ISO13485, ISO14971
PROFESSIONAL EXPERIENCE
Beckman Coulter Genomics (Molecular Diagnostics), Danvers, MA
2011-2012
Staff Quality Assurance Scientist, Quality Assurance supporting a multi-million dollar development project
Quality Assurance representative supporting four novel automated molecular diagnostic assays based on real-time PCR.
Contributed as Subject Matter Expert to research and development discussions, experimental designs, project plans,
technical reviews, design reviews, documentation, product assessment and risk management.
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Coordinated, standardized and maintained the Design History Files for four assays containing 100’s of documents in
an electronic document management system (EDMS).
Reviewed over 100 documents for content and completeness in accordance with good document practice and ensured
traceability of documents and actions stemming from assisted technical and design reviews.
Identified product inputs and defined 10 plus inputs per product in terms of measurable criteria in line with CLSI
guidelines across the design description documents for four assays.
PIERRE J. LEVASSEUR, Ph.D.
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(978) 255-1765 / (617) 462-5201 (mobile)
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Reviewed countless test plans, protocols, and reports supporting R&D activities in product evaluation, verification
and validation, and transfer activities evaluating product manufacturability and product specifications.
Authored and executed IQ/OQ/PQ test plans, protocols and reports in a $250,000 Facility’s equipment installation.
Provided R&D group training in risk analysis and facilitated process and design failure mode and effects analyses to
ensure product reliability and safety for four assays.
Exiqon, Inc. (MicroRNA Research), Woburn, MA
2007-2010
Senior Technical Support Scientist, Technical Support supporting high value products earning tens of $M in USA
Member of international Technical Support Team for specialty products based on Locked Nucleic Acid (LNA™)
technology. Key resource for product applications and design of custom LNA probes and primers used in microRNA,
noncoding RNA and messenger RNA detection and functional analysis. Expertise in design, evaluation and analysis of
microRNA profiling experiments based on array hybridization and quantitative RT-PCR approaches.
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Daily interaction with customers handling technical, result and experimental inquires by phone and e-mail - hundreds
of inquires handled on a monthly basis.
Designed over a thousand probes and primers for microRNA (and RNA) detection and functional analysis based on
LNA™ technology using proprietary oligonucleotide design algorithms and web resources.
Provided customers with expert advice on microRNA microarray and RT-PCR profiling experiments, validation
studies, choice of reference genes for comparative quantification, expression analysis, and on use of analysis software.
Instructed customers on functional analysis studies using microRNA antagomirs and mimics, and on microRNA (and
mRNA) localization studies using in situ hybridization.
Supported six Sales Representatives/Account Managers in customer relations through technology presentations,
technical conferences and web meetings.
Coauthored scientific publication stemming from collaborative project.
PerkinElmer Life and Analytical Sciences (R&D Center of Excellence), Boston, MA
2006-2007
Principal Scientist, Research and Development supporting a multi-million dollar development project
Led team of four scientists in development and launch of a novel bead-based array, gene expression profiling platform.
Executed feasibility, development, verification and transfer phases. Provided technical expertise.
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Launched three products as part of a new, comprehensive product line: a bead-based Gene Expression Detection Kit,
a Customizable Expression Panel, Data Analysis Software.
Met aggressive nine month launch date by streamlining product development process: focused project plans and
experimental approach on essential design requirements while ensuring sound validation and quality of product.
Generated user manuals and promoted product. Authored and presented two posters at scientific meetings.
IDEXX Laboratories, Inc. (Veterinary Diagnostics), Westbrook, ME
2004 – 2005
Research Scientist III, Research and Development supporting development of a $12.8M EVA product
Project Leader for development of a multiplex immuno-diagnostic assay. Coordinated multidisciplinary and R&D Teams
in project planning and execution. Led five R&D scientists in prototype design, development and evaluation.
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Advanced Project Charter for development of a multiplex immuno-diagnostic assay as Core Team Leader.
Drafted Product Development Plan and schedule through consultation with extended multidisciplinary team of over
20 members from R&D, Technical Support, Marketing, Quality, Regulatory, Operations, Purchasing, Finance, Legal.
Streamlined product development process by focusing activities on milestones, and used parallel tasking to accelerate
the assembly and evaluation of prototype designs saving months on schedule.
Turned suboptimal multiplex assay into promising product by resolving a reagent incompatibility issue.
Increased clinical specificity of assay by redesign of a critical recombinant test component. Directed multidisciplinary
team consisting of the Molecular Biology Group, R&D, and Technical Support in effort.
Demonstrated readiness of product for development and issued QC procedures to guarantee product performance.
PIERRE J. LEVASSEUR, Ph.D.
(978) 255-1765 / (617) 462-5201 (mobile)
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BIOMÉRIEUX, INC. (Molecular Diagnostics), Durham, NC (Formerly Rockland, MA)
1992 - 2004
Senior Staff Scientist, Research and Development supporting a long-term multi-million dollar project
Led Project teams and R&D teams of one to three scientists in development and manufacture of novel molecular
diagnostic assays. Realized project plans, experimental plans, reports and reviews. Designed and tested prototype
devices and assays. Trained technical and non-technical teams in advanced technologies.
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Co-designed and co-developed a novel Quantitative HIV-1 Assay. Directed product transfer to Manufacturing.
Established product specifications. Trained Operations in reagent preparation and Quality Control procedures.
Led development and demonstrated feasibility of three additional molecular diagnostic assays: Neisseria gonorrhoeae
Assay, Neisseria gonorrhoeae/Chlamydia trachomatis (Combo) Assay, Methicillin Resistance (mecA) Gene Assay.
Successfully adapted a licensed technology to an established platform. Adapted disposable. Developed assay
procedures and instrument protocols. Resolved issue with solid support capture impacting five molecular diagnostic
assays under development. Introduced internal control for run validation. Formulated data analysis procedures.
Authored design control documents including test protocols, reports, specifications, BOMs, MCPs, QCPs, SOPs.
Co-authored and presented 10 posters at scientific meetings.
Co-led international, bilingual collaborative team in genetic reengineering project for a polymerase enzyme in
development of a novel amplification technology while an expatriate in France. Responsible for technical exchange,
contract obligations, project reviews and reports.
EDUCATION
Ph.D., Cell & Molecular Biology, The University of Illinois at Chicago, Chicago, IL
M.S., Biochemistry and Physiology, The University of Illinois at Chicago, Chicago, IL
B.S., Biology, Math, Teaching Certificate, Grand Valley State University, Allendale, MI
Post-Doctorate, Yale University, New Haven, CT
Project Management Certification, PMP Course, Boston University, Boston, MA
Quality System Regulation Certification, Association for the Advancement of Medical Instrumentation