Jennifer Dally
Director CMC Analytical Project Leadership at GSK
- Role
- Director Biopharmaceutical Analytical Project Leadership at GSK
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Jennifer Dally
GlaxoSmithKline (GSK) is a science-led, global healthcare company that researches and develops innovative products. GSK currently employ over 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.
Experience
Director Biopharmaceutical Analytical Project Leadership
Jan 2018 — Present · King of Prussia, PA, US
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.
Education
University of the Sciences in Philadelphia
Doctor of Philosophy (Ph.D.), Analytical Chemistry
1998 — 2007
Philadelphia. College of Pharmacy and Science
Bachelor's Degree, Chemistry
1993 — 1997
Skills
- Gmp
- Biopharmaceuticals
- Biotechnology
- Good Laboratory Practice (Glp)
- Life Sciences
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