Dawn (Serio) Kelly, Ph.D Email & Phone Number

Rahway, New Jersey, Us

Leader of the Device, Drug Device Combinations Regulatory Team with primary responsibility for ensuring effective development and implementation of scientifically sound regulatory device and combination product strategies, developing content for global submissions and interacting with regulators. Accountable for all device and combination products in the Merck portfolio and commercial products across all modalities.

Rahway, New Jersey, Us

Manage CMC team responsible for global CMC support of Merck''s biologic post approval portfolio, including Monoclonal antibodies and Womens Health products.

Rahway, New Jersey, Us

Group head providing CMC regulatory support for Merck's Vaccine portfolio of combination products. Chief of Staff supporting Associate Vice President and Global Head, GRACS-CMC Biologics, Medical Devices and Combination Products.

Tel-Aviv, Il

Provides Global CMC regulatory support (Strategy, Guidance, Submissions) in the lifecycle management of women's branded health care products: steroids, combination products (rings and applictators), gels, cremes, solid oral dosage forms. Global reglatory leader managing and drving global strategy within context of global Clinical and CMC regulatory team.

Tel-Aviv, Il

Provides Global CMC regulatory support (Strategy, Guidance, Submissions) in the lifecycle management of monoclonal antibody combination products in addition to steroids, vaginal rings and applictators, gels, cremes, solid oral dosage forms. Experienced Global regulatory leader managing and driving global strategywithin context of global project team.

Tel-Aviv, Il

Senior Manager, CMC regulatory. Providing CMC regulatory support (submissions, strategy and guidance) in the lifecycle management of women's health care products: steroids, combination products (rings and applictators), gels, cremes, solid oral dosage forms.

Brentford, Middlesex, Gb

Manage, direct and submit Biopharm CMC pre-approval documentation on behalf of Biopharm CEDD. Participation on project teams, and key contributor to filing strategy for Mabs and small biopharm molecules. Interactions with US, Canada and EU agencies.

Brentford, Middlesex, Gb

Technical transfer of cell culture technologies from development and our UK facility to clinical production within GSK.Prepare and approve GMP documentation to support manufacturing processes.Manage virus testing of Cell Culture material in compliance with the US and EU guidelines.Train/supervise cell culture team and plan development and training of new personnel.Oversee cryostorage and End of Production functions and represent these areas on project teams.Represent clinical manufacturing organization on project teams.Participate in audits of vendors providing raw materials and services used in manufacturing process.Innovate and implement new technologies.Contribute technical regulatory guidance to assigned project teams to ensure strategic implementation necessary for manufacturing changes in compliance with cGMPs and provide appropriate regulatory documentation.Develop and maintain intimate knowledge of FDA and EP regulations and ICH guidances as they relate to biopharmaceuticals.

Brentford, Middlesex, Gb

Oversee all GMP and non-GMP mammalian and bacterial Banking activities and documentation.Supervision, instruction and development of staff.Maintenance of laboratories in an inspection ready state.GMP protocol and assay development.Participation in the senior Quality forum excellence group to ensure delivery of quality product.Provide Regulatory assistance and guidance.Participation on project task force groups.ISO 9001:2000 certification completed.

Phd, Microbiology And Molecular Virology

Bs, Biology