Kelly Levasseur's Location
Greater Boston, United States, United States
Kelly Levasseur's Contact Details
Kelly Levasseur work email
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Kelly Levasseur personal email
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About Kelly Levasseur
Experienced technical professional with demonstrated success in project management, specializing in process analysis and continuous improvements. Detail-oriented scientist with strong technical writing, editing, communication, problem solving, prioritization, and computer skills. Recognized for work ethic, relationship management, keen proficiency in quality systems, quality/regulatory compliance, and data integrity review. Adept working in both cross-functional team collaboration and independently, with ability to multitask in a high-pressure environment.
Kelly Levasseur's Current Company Details
Quality Control Stability Lead
Kelly Levasseur Work Experience Details
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Sr Manager Qc Stability, Technical OperationsInvivyd Apr 2021 - May 2024Waltham, Massachusetts, Us• My contributions were instrumental in getting FDA’s Emergency Use Authorization (EUA) for Pemgarda,our COVID-19 monoclonal antibody, from initial concept to commercial ready in just over a 1 yeartimeframe, and toward the successful acceptance of the INVYMAB™ platform-based approach for thecontinuous rapid discovery and optimization of monoclonal antibody candidates to keep pace with viralevolution• As the only Stability SME ever at the company, I built out the entire Stability program infrastructure• Established, oversaw, updated, and maintained drug substance and drug product stability programs,including oversight of external laboratories• Authored stability sections of regulatory filings (key contributor to IND, IMPD, EUA submissions) andresponded to inquiries from health authorities• Assigned and extended shelf-life of drug substance and drug product, ensuring there were nointerruptions in clinical trials• Authored stability reports and Annual Product Reviews for products• Ensured timely initiation of stability studies and that they met ICH guidelines• Created data tables, performed trending analysis of data, and facilitated timely investigation of out-ofspecification/out-of-trend result occurrences• Initiated and managed Change Controls for stability related activities• Provided technical and documentation support as the Stability SME, and presented regular stabilityupdates to Technical Operations and Quality groups• Established and presented meaningful stability metrics internally and externally for QMR, and initiatedprocess improvements• Authored Stability and Shelf-Life SOPs and Forms• Participated in the establishment of drug substance and drug product specifications• Provided stability assessments as needed for product temperature excursions• Managed Tech Ops’ Reference Standard and Critical Reagent Inventory Tracker• Facilitated stability sample identification and transfers when needed to aid development testing -
Qc Stability ManagerTakeda Dec 2017 - Apr 2021Tokyo, Jp• Stability Study program management of numerous clinical/commercial biologics, small molecules, and cell banks, internal to Takeda and external with CMOs/CLOs; As a lead Subject Matter Expert, supported operational and technical aspects of drug substance and drug product GMP stability programs, ensuring compliance and supporting company Standards, Practices, and SOPs as well as ICH and FDA guidelines, including design of stability protocols, enrolling lots on stability for Annual Commitments, For Cause, Conformance, and Validation studies, authoring stability reports and regulatory submissions, technical assessments of data, specification changes, investigations, initiation/completion of quality systems, temp excursions, inspection support, ensuring timelines were met for stability testing of product, trending data proactively, and vendor procurement/payment activities• Compliance Lead for team• Contributed meaningful stability performance metric data to leadership for tier-board visibility, and reported CLO performance/turnaround metrics • Essential contributor toward 2 company integrations and Global Stability integration, driving process improvements and harmonization, with follow-up roles on multiple departmental and cross-functional workstream teams formed to drive the initiatives/changes to completion• Assisted with oversight of group training, organizing requirements for the team to eliminate non-value added courses, add missing courses, and reduce training roles to define team members more accurately• Mentored team members in Stability group -
Qc Stability ManagerShire Dec 2017 - Jan 2019Tokyo, Jp, Jp(Shire merged with Takeda) -
Stability & Compliance Specialist/Pharmaceutical DevelopmentShire Feb 2016 - Dec 2017Tokyo, Jp, Jp• Sought out and performed process improvements as essential contributor in Value Stream Analysis and Kaizen events• Managed development stability studies, including study execution, creation/management of sample pull schedule, coordination of sample pulls/preparation/submission/testing, follow through for on-schedule data delivery (internal and external contract labs), summarization and archival of data, management of inventory, maintenance of equipment, and data management in alignment with regulatory guidance documents• Supported multiple cross-functional CMC teams to meet stability needs for clinical programs in all stages of development• Developed/maintained standard operating procedures and systems for management of stability activities• Generated and implemented related quality systems• Assembled and maintained data tables, tracked and trended data• Authored/reviewed stability reports• Provided support for regulatory filing activities• Mentored and trained Stability Coordinator
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Quality Control Specialist, Quality Control (Contractor)Alexion Pharmaceuticals, Inc. Sep 2015 - Dec 2015Boston, Massachusetts, Us• Compiled, analyzed, and wrote Expiry, Forced Degradation, Comparability and Validation reports based on stability data results• Provided support for regulatory filing activities• Tracked and trended data using JMP analysis• Assembled and maintained stability data tables for drug substance and drug product• Created and reviewed Certificates of Analyses• Supported activities related to CMOs/CLOs -
Specialist, Finance-Contract ServicesAct Jul 2014 - Jun 2015Remote, Us• Implemented corporate contract repository in SharePoint - indexed >4000 customer and vendor contracts, coordinated off-site scanning, converted pdfs for searchable text, uploaded to repository, assigned properties for search functions; granted SharePoint permissions to individuals as needed, trained individuals in using the repository • Organized hardcopy contract files spanning back >50 years per corporate retention policy and established archive process, purging expired contracts and duplicates, coding hold time on remaining ones based on term dates• Evaluated procedures and implemented changes necessary to streamline processes and improve the group’s turnaround time and customer service• Administrator for lawyers and contract managers, maintaining high level of confidentiality and security regarding corporate and personnel information and documents -
Data Mining Specialist, Talent Strategy-Talent Aquisition (Contractor)Act Mar 2014 - Jul 2014Remote, Us• Prepared for confidential, time sensitive audit by retrieving information from various applicant data systems, documenting discrepancies, and organizing collected data in electronic format• Discovered and corrected errors in reporting spreadsheet, documented gaps in data reporting systems and applied logical thinking to minimize risk, leading to issue-free closure letter for a >2-year investigation
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Chemical Formulations Technician, Solid Support Manufacturing (Contractor)Integrated Dna Technologies Nov 2013 - Jan 2014Coralville, Ia, Us• Sintered polyethylene powder into restrictive frits for use in oligonucleotide synthesis• Significantly improved quality of frits, resulting in improved productivity downstream• Management of records using inventory management system -
Sr. Scientist, Quality Control Stability (Remote Contractor)Shire Human Genetic Therapies Apr 2012 - Dec 2012Tokyo, Jp, Jp• Authored 124 reports to successfully close out backlog and prepare for regulatory audit responses• Sought out and performed continuous improvement activities, including streamlining reports • After identifying specification discrepancies, performed gap analysis of all products to find lots/time points impacted in preceding 5 years; used analysis to coordinate deviations and change controls to implement revisions to protocols and reports• Worked with IT team in development and execution of dynamic data cleansing project in Laboratory Information Management System (LIMS), implemented to aid in generation of future stability reports within LIMS; involved ~1000 sample reactivations, upgrades/redesigns of builds and inclusion of additional test results• Reviewed/approved final test results in LIMS, ensured testing was performed on time, contacted labs for overdue/out of specification/out of trend results; prepared monthly calendars to alert labs and stability group of upcoming study time point testing; entered, tracked and trended data• Reviewed regulatory submissions, investigation and trend reports, protocols, and Standard Operating Procedures (SOPs)
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Sr. Associate Scientist Ii, Global StabilityBiogen Idec Jun 2004 - Dec 2011Cambridge, Ma, UsGlobal Stability, QA/QC/Product Quality Management group (worked remotely the last 3 years)• Supported operational and technical aspects of clinical (pre-clinical to Phase 3 trials) and commercial drug substance, drug product, placebo, and reference standard GMP stability programs for >40 biologics and small molecules• Ensured departmental compliance with professional guidelines, company standards, practices, and SOPs • Managed clinical expiry dating program for drug substance, drug product, placebo, and reference standard material -
Lab Manager, Department Of Biochemistry And Molecular GeneticsUab May 1985 - Apr 2004Birmingham, Al, UsAnalytical protein biochemist• From 1991-2004, independently managed the UAB Protein Analysis Core Facility, providing amino acid/hexosamine composition and N-terminal protein/peptide sequencing services to researchers worldwide. Executed all aspects of sample preparation, throughput, data analysis and all administrative duties necessary to run the lab. The Facility was maintained primarily by self-generated revenue and partially subsidized by the Comprehensive Cancer Center.• From 1985-1990, performed broad range of biochemistry bench research (e.g. various types of chromatography, electrophoresis, Western Blots, protein assays, carbohydrate assays, ELISA, radioimmunoassay, chemical distillation, hydrolysis, titration, dialysis, spectrophotometry, densitometry, centrifugation, lyophilization, evaporation, gamma and scintillation counting, fraction collecting, sonication and analytical milling); assisted in designing, executing and troubleshooting experiments; maintained and modified scientific instrumentation; prepared and marketed proteoglycans for ICN Biomedicals; prepared graphic illustrations for publications and presentations; assisted in writing and editing grant applications and research manuscripts for publication in scientific journals.
Kelly Levasseur Skills
Gmp
Protein Chemistry
Biotechnology
Lims
Biopharmaceuticals
Biochemistry
Glp
Cancer
Assay Development
Quality Control
Proteomics
Quality System
Project Management
Change Control
Hplc
Chromatography
Elisa
Purification
Protein Purification
Immunoassays
Trackwise
Quality Assurance
R&d
Regulatory Submissions
Lotus Notes
Metrics
Continuous Improvement
Technical Writing
Editing
Stability
Fda/ich Guidelines
Track/trend Data
Sop Development/authoring
Data Tables/data Integrity Review
Gap Analysis
Expiry
Deviations/oos/oot
Protein/peptide N Terminal Sequencing
Amino Acid/hexosamine Composition
Contract Labs
Cmos/cros
Html/web Design
Sds Page
Ms Office
Adobe Professional
Jmp
Sigmaplot
Visio
Edocs
Sharepoint
Kelly Levasseur Education Details
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University Of Alabama At Birmingham
Frequently Asked Questions about Kelly Levasseur
What is Kelly Levasseur's role at the current company?
Kelly Levasseur's current role is Quality Control Stability Lead.
What is Kelly Levasseur's email address?
Kelly Levasseur's email address is kl****@****eda.com
What is Kelly Levasseur's direct phone number?
Kelly Levasseur's direct phone number is +131959*****
What schools did Kelly Levasseur attend?
Kelly Levasseur attended University Of Alabama At Birmingham.
What skills is Kelly Levasseur known for?
Kelly Levasseur has skills like Gmp, Protein Chemistry, Biotechnology, Lims, Biopharmaceuticals, Biochemistry, Glp, Cancer, Assay Development, Quality Control, Proteomics, Quality System.
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