-- PhD with 6+ years related experience, or Master's Degree in related scientific field with 10+ years related experience, or Bachelor's Degree in related scientific field with 12+ years related experience. Total education and experience in vaccines-related domain of 10 years.
-- Hands-on and in-depth understanding of different protein chemistry characterization and stabilization techniques, as well as pharmaceutics relevant to drug product development including lyophilized, liquid and suspension dosage form in vial.
-- Good understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of vaccine and/or biologics with some knowledge of Quality by Design also desirable.
-- The qualified candidate must be able to effectively partner with diverse team members from various functions within vaccines, multiple countries, and members at various levels within the organization.
-- Must be a self-starter, be able to work with minimal supervision in a matrix environment and effectively manage multiple projects.
-- Regulatory experience in multiple geographical regions (US, EU, Asia), as well as formulation and process tech transfer experience is a plus.
-- A thorough understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required.
-- Knowledge about physical characterization of the vaccine formulations using high-end instrumentation is required.
-- Ability to effectively work, perform, and lead within a team of dedicated scientists is essential.
-- Must be able to solve complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment.
-- Requires conceptual and practical experience with the project management function.
-- Experience in technology transfer and scale-up of drug product processes is a plus.
-- Management experience is required. The Senior Manager will have from 4 to 8 direct reports.
Help establish the U.S. Drug Product Development function in Rockville, MD. Expected to lead and represent drug product development function on formulation and process development projects in a cross function matrix team environment and assist in regulatory filings.
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