Barbara Ressler

Vice President, Manufacturing Process Sciences @RoslinCT

Boston, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2023 — Present

Vice President, Manufacturing Process Sciences @RoslinCT

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Hopkinton, MA, US

EDUCATION

1995

Massachusetts Institute of Technology

S.M., Mechanical Engineering

1993 — 1999

Massachusetts Institute of Technology

Ph.D., Mechanical Engineering

1989 — 1993

Northwestern University

BS, Biomedical Engineering

SKILLS

GmpProcess DevelopmentProject ManagementIq / Oq / Pq ProtocolsAssay ValidationCell CultureFda GmpFinite Element AnalysisDocumentationGmp / CgmpAssay DevelopmentGlpDesign SpecificationsTechnical WritingDesign ControlHigher EducationDevelopment of SopComputational Fluid DynamicsTechnology DevelopmentFmeaJmpProcess TransferFluid MechanicsFda Regulatory EnvironmentDesign of ExperimentsMechanical EngineeringHuman FactorsMentoringScale-UpMedical DevicesImage AnalysisValidationStatistical AnalysisTechnology TransferSop AuthoringStatistics

ABOUT BARBARA RESSLER

Contact Barbara Ressler, P••••••••@gmail.comExpert in project coordination, interfacing effectively with contracted labs, senior management, regulatory, and quality organizations. Repeated success unifying cross-functional teams and building collaboration, translating to on-time and within-budget project completion. Credited with taking early-stage cell-therapy products and successfully preparing for clinical trials and BLA. Experienced managing teams of scientists and engineers for the development of robust products and processes. Completed development and validation of all assays for orphan tissue-based product in 18 months. Medical device project management from feasibility studies through V&V testing, design dossier and DHF assembly, preparation for 510(k) submission, and obtaining 510(k) clearance.

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