Lori Fischer

Principal Engineer, Cmc Drug Product Device Development @Novo Nordisk

Boulder, CO, US
MOBILE NUMBERS
+19•••••••07

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WORK HISTORY

Jan 2022 — Present

Principal Engineer, Cmc Drug Product Device Development @Novo Nordisk

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Dicerna Pharmaceuticals was acquired by Novo Nordisk in December 2021.

EDUCATION

N/A

Rochester Institute of Technology

Bachelor of Science (BS), Packaging Engineering

SKILLS

Product DevelopmentAseptic ProcessingPharmaceuticsU.s. Food and Drug Administration (Fda)LifesciencesManufacturingValidationR&DPackaging EngineeringCross-Functional Team LeadershipPackagingBiotechnologyResearch and Development (R&D)Medical DevicesCapaPackaging DesignQuality SystemV&VPharmaceutical IndustryFdaGmp

ABOUT LORI FISCHER

30 years’ experienced pharmaceutical and medical device professional with proven track record for developing combination products implementing design control practices, creating design history files (DHF), and successful FDA NDA approvals. Extensive experience with prefilled syringes, sterile barrier packaging, labeling and artwork, qualification of manufacturing equipment, and in-depth knowledge of ISO, FDA, cGMP, and CFR regulations and guidance’s related to pharma and parenteral products. Worked in every facet of industry from early phase clinical supply to new product development, technical transfer, commercialization, and sustaining engineering. Easily adaptable with additional skills in purchasing, quality audits, regulatory submission responses, people management, and project management capabilities.

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Lori Fischer — Email, Phone Number & Contact Info | Unifers