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GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 100,000 people globally and has offices in more than 115 countries. At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better, live longer. We need a talented, motivated and resilient workforce if we are to deliver against our strategy and tackle global health challenges effectively. To achieve this, we aim to create a working environment where employees feel valued, respected, empowered and inspired. R&D innovation underpins all of our businesses. We partner with more than 1,500 other companies and academic organizations around the world, enabling us to increase our understanding of new areas of science and to share the risk of development. We have a deep portfolio of innovation focused across six core areas of scientific research and development: HIV and infectious diseases, oncology, immuno-inflammation, vaccines, respiratory and rare diseases. Personally, I have more than 20 years of experience in leading R&D and commercial analytical development projects and have demonstrated expertise in QbD approaches to analytical lifecycle management, new platform technology development, analytical method development and validation, and regulatory strategy. My current role is Director of Biopharmaceutical Analytical Project Leadership which has afforded me the opportunity to provide scientific and operational leadership to CMC project teams for development and delivery of stage appropriate analytical strategies for Biopharmaceuticals.
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Director Biopharmaceutical Analytical Project LeadershipGsk Jan 2018 - PresentKing Of Prussia, Pennsylvania, United StatesBuilt and implemented the Analytical Work Stream department (Analytical Project Leadership) within the Biopharmaceutical Development organization. Lead a team responsible for providing scientific and operational leadership to CMC project teams for development and delivery of stage appropriate analytical strategies for biopharmaceuticals. Manage interactions with CMO/ CRO for manufacturing and testing of clinical and commercial launch materials, analytical technology transfer and… Show more Built and implemented the Analytical Work Stream department (Analytical Project Leadership) within the Biopharmaceutical Development organization. Lead a team responsible for providing scientific and operational leadership to CMC project teams for development and delivery of stage appropriate analytical strategies for biopharmaceuticals. Manage interactions with CMO/ CRO for manufacturing and testing of clinical and commercial launch materials, analytical technology transfer and validation approaches, continuous assay performance monitoring, product characterization and CMC support for regulatory filings and agency interactions including US, EU, CA, JP and emerging markets. Lead the overall analytical lifecycle of products through implementation of QbD approaches including assessing the relationship among Quality Target Profile, Critical Quality Attributes, Critical Process Parameters, and Testing Strategy. Show less -
Director Biopharmacetical Analytical Development - Protein Separations And Impurities AnalysisGsk Oct 2016 - Jan 2018King Of Prussia, Pennsylvania, United StatesManaged team responsible for the development and validation of phase appropriate analytical methods supporting release, stability, in-process, and characterization testing. Responsible for review and approval of analytical CMC sections for regulatory files. Responsible for establishing and overseeing an on-site contract analytical laboratory that supported testing for all large molecule process and formulation development. studies. -
Manager Biopharmaceutical Analytical Development - Protein SeparationsGsk Oct 2011 - Oct 2016King Of Prussia, Pennsylvania, United StatesLaboratory supervisor for team of scientists responsible for phase appropriate analytical development, product characterization, and comparability studies. Responsible for the preparation of analytical CMC sections for regulatory files. Established matrix team to ensure analytical harmonization across R&D and manufacturing testing laboratories. Coordinated analytical investigations internally and facilitated investigations between GSK and contract facilities. Led the analytical… Show more Laboratory supervisor for team of scientists responsible for phase appropriate analytical development, product characterization, and comparability studies. Responsible for the preparation of analytical CMC sections for regulatory files. Established matrix team to ensure analytical harmonization across R&D and manufacturing testing laboratories. Coordinated analytical investigations internally and facilitated investigations between GSK and contract facilities. Led the analytical work-stream matrix team for the development and registration of Nucala (mepolizumab), a first in class mAb for the treatment of eosinophilic asthma. Led all aspects of the analytical strategy from Phase II through commercialization in US, EU, Canada and Japan, Accountable for all analytical activities to support commercialization including technology transfer, validation, CQA identification and structure function understanding, specifications, and regulatory agency interactions. Show less -
Senior Scientist/ Investigator Biopharmaceutical Analytical DevelopmentGsk May 2001 - Oct 2011Led the analytical work-stream matrix team for the development and registration of Arzerra (ofatumumab). Led aspects of the analytical strategy from Phase III through commercialization in US, EU, Canada and Japan. Responsible for analytical activities to support commercialization including CQA identification and structure function understanding, specifications, and regulatory agency interactions. Biopharmaceutical analytical scientist responsible for development and validation of… Show more Led the analytical work-stream matrix team for the development and registration of Arzerra (ofatumumab). Led aspects of the analytical strategy from Phase III through commercialization in US, EU, Canada and Japan. Responsible for analytical activities to support commercialization including CQA identification and structure function understanding, specifications, and regulatory agency interactions. Biopharmaceutical analytical scientist responsible for development and validation of phase appropriate analytical HPLC and MS methods supporting release, stability, in-process, and characterization testing. Responsible for protein characterization and structure function studies to support product understanding and CQA identification. Show less -
Scientist Protein BiochemistryGsk May 1999 - May 2001King Of Prussia, Pennsylvania, United States
Jennifer Dally Skills
Jennifer Dally Education Details
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Analytical Chemistry -
Philadelphia. College Of Pharmacy And ScienceChemistry
Frequently Asked Questions about Jennifer Dally
What company does Jennifer Dally work for?
Jennifer Dally works for Gsk
What is Jennifer Dally's role at the current company?
Jennifer Dally's current role is Director CMC Analytical Project Leadership at GSK.
What is Jennifer Dally's email address?
Jennifer Dally's email address is je****@****ail.com
What is Jennifer Dally's direct phone number?
Jennifer Dally's direct phone number is +121530*****
What schools did Jennifer Dally attend?
Jennifer Dally attended University Of The Sciences In Philadelphia, Philadelphia. College Of Pharmacy And Science.
What skills is Jennifer Dally known for?
Jennifer Dally has skills like Biopharmaceuticals, Gmp, Biotechnology, Good Laboratory Practice, Life Sciences.
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