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Dorie has nearly 30 years in the Pharmaceutical sector, her expertise is in solid dosage formulation and process development from pre‐clinical through marketing application. Her development experience has included compressed tablets using roller compaction, wet granulation (continuous, high shear, and fluid bed) melt granulation and direct compression processing, hot and low melt extrusion, aqueous tablet coating and filling of hard gelatin capsules.Dorie facilitated and conducted GEMBAs of GSK products at over 8 global manufacturing sites and assessed them for process robustness to identify areas for increased product yield and quality. She designed and implemented projects and experiments for process improvements to enhance overall product quality and yield. She is passionate about the need to develop robust processes to ensure quality for patients and efficiency for manufacturing.A technical leader with over 22 years experience in formulation and process development of multiple NCE and line extension products coordinating drug product formulation, manufacturing process and development, scale-up and transfer to global manufacturing sites. She has contributed to several cross-functional initiatives (market image branding, technical risk assessments, control strategy, and process validation exercises) of multiple oral solid dose products.
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OwnerD^2 Consulting, Llc Mar 2017 - 2020
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Senior ConsultantVerta Life Sciences Jan 2017 - 2019 -
Scientific InvestigatorGsk 2013 - 2016Rtp, Nc• Received exceptional science award for developing a novel formulation and low melt extrusion pelletization processing capabilities to improve the robustness of a legacy product • Facilitated and conducted GEMBAs of current products at global manufacturing sites and assess for process robustness to identify areas for increased product yield and quality• Designed and implemented projects and experiments for process improvements to enhance product quality and yield • Authored and reviewed US and foreign regulatory dossiers, validation protocols, technical transfer documents, development reports, protocols and global manufacturing guides -
Scientific Investigator/Formulation ScientistGlaxosmithkline 2009 - 2013Rtp, Nc• Successfully reformulated late stage in-licensed compound and developed scale-up capability of roller compaction process resulting in an exceptional science award• Achieved exceptional science award for leading the manufacturing scale-up and transfer activities from pilot plant to global manufacturing for a high profile product and consistently meeting clinical timelines• Product Development Team leader, coordinated drug product formulation, manufacturing process and development, scale-up and transfer to global manufacturing site• Contributed to several cross-functional initiatives (market image branding, technical risk assessments, control strategy, and process validation exercises)• Authored and reviewed regulatory dossiers, validation protocols, technical transfer documents, development reports, protocols and global manufacturing guides• Trained scientists and operators in the proper use of various manufacturing equipment -
Senior ScientistGsk 2005 - 2009Rtp, NcProduct Development/Technical Transfer Team leader• Received an exceptional science award for developing a novel PEG based formulation to overcome the saturable absorption observed for the molecule• Supervised and coordinated clinical trial manufacturing activities delivering 100% on-time quality patient product• Introduced novel drug product processing using twin screw technology to improve the manufacturing capability of a high profile product and consistently meeting clinical demands• Chaired product development safety team and managed monthly safety inspections for 40 analytical and formulation labs and 125 personnel resulting in corporate audit meeting 100% expectations -
Formulation ScientistGsk 2000 - 2005Rtp, Nc• Developed new and reformulated drug products and manufacturing capabilities for transfer into global manufacturing sites for capsules, tablets, ointments, creams and liquid products• Conducted Gamma Scintigraphy Studies, including operation of the gamma camera, data acquisition, identifying regions of drug product absorption, animal dosing and handling, and creating study protocols• Developed Flavor Website for product development group • Developed and established contractual agreements with Flavor and Sensory Companies for flavor development of oral dosage forms -
Associate Research ScientistGlaxo Welcome Inc 1995 - 2000Rtp, Nc• Organized process development and scale-up of non-sterile liquid and semi-solid dosage forms for new and reformulated products • Assisted in product transfers for all ointment, cream and liquid products transferred to global manufacturing sites• Assisted in resolving production problems encountered during normal manufacturing
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ScientistAbbott 1987 - 1995Abbott Park Gurnee Il• Coordinated the efforts needed to acquire GMP status for a small laboratory containing HTLV-I infected cell lines for large scale anti-body production using hollow fibers received Abbott Laboratories Presidential Award• Developed advanced anti-body production using hollow fibers for cell culture growth, demonstrating 98% purity• Conducted hybridization, cell fusions, cloning, and scale-up from micro titer plates to flasks, roller bottles and/or hollow fiber systems of viral infected and non-infected cell lines • Performed stability testing on new and reformulated Abbott Diagnostic Division (ADD) products
Dorie D'Haene Skills
Dorie D'Haene Education Details
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Cytotechnology/Cytotechnologist -
Biology, General
Frequently Asked Questions about Dorie D'Haene
What is Dorie D'Haene's role at the current company?
Dorie D'Haene's current role is Senior Consultant at Verta Life Sciences.
What is Dorie D'Haene's email address?
Dorie D'Haene's email address is dj****@****gsk.com
What is Dorie D'Haene's direct phone number?
Dorie D'Haene's direct phone number is (215)-751*****
What schools did Dorie D'Haene attend?
Dorie D'Haene attended University Of Michigan, Jackson Community College.
What are some of Dorie D'Haene's interests?
Dorie D'Haene has interest in Animal Welfare, Children.
What skills is Dorie D'Haene known for?
Dorie D'Haene has skills like Process Engineering, Clinical Development, Drug Development, Gemba, Lean Manufacturing, Fda, Regulatory Affairs, Capa, Experimental Design, Glp, Change Control, Pharmaceutics.
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