Senior Regulatory Scientist - (US-PA-West Point - 19486)

Minimum Education: Tech School
Job Type: Full Time
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Merck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.



Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


Utilizing information from MRL/MMD scientists and MMD production and quality personnel prepares chemistry manufacturing and controls (CMC) sections for new biological products license supplements to existing biological product license applications (BLAs) or marketing authorization applications (MAAs) for US Europe and the rest-of-world (ROW).



Under direction of a Manager or Director is responsible for implementing CMC regulatory strategies for Mercks biological product franchise in accordance with domestic and international regulations.



Works independently to compile data and information in support of new and in-line bio product licenses/registrations worldwide. Reviews proposed changes in the manufacturing testing or packaging of a bio drug substance/product and provides recommendations regarding the potential regulatory impact on product registration. Coordinates and prepares the post-approval documentation (Annual Reports license renewals etc) for submittal to the appropriate agency to assure compliance with existing registrations.



This position is in the Viral Bulk Franchise which supports M-M-R®II RotaTeq® VARIVAX® ProQuad® ZOSTAVAX® VAQTA® and Antivenin.



Please note relocation assistance is not provided for this position.
Required:

Minimum 5 years of experience in biological/pharmaceutical research or manufacturing to include activities directly related to manufacturing testing or licensure of biological products.
B.S. MS or Ph.D. and demonstrated technical expertise in cell biology virology molecular biology and/or microbiology. M.S. or Ph.D. preferred.
Demonstrated effective leadership communication interpersonal and negotiating skills.
Advanced knowledge of regulatory aspects of in-line and new biological products required; knowledge as applied to vaccines preferred.
Sound demonstrated understanding of related fields (e.g. manufacturing analytical quality assurance).
Ability to be creative and imaginative in the approach to new and diverse problem solving.

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