Develop and implement Regulatory Chemistry, Manufacturing & Controls strategies
Serve as the CMC Product Lead or support the CMC Product Lead for assigned projects
Lead development and execution of global product and project regulatory strategy
Execute regulatory strategies by leading the development, authoring and review of CMC submission components
Provide regulatory leadership as needed to product in-license/due diligence review
Collaborate with Organon Manufacturing & Supply colleagues and external partners
Requirements
Bachelor’s Degree in science, engineering, or related field
At least 7 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree with at least 4 years of relevant experience
At least four (4) years of relevant experience
Proficient in English; additional language skills are a plus
Proven experience in critically reviewing scientific information
Demonstrated superior oral and written communication skills
Strong listening skills
Demonstrated sound understanding of related fields
Benefits
retirement savings plan
paid vacation and holiday time
paid caregiver/parental and medical leave
health benefits including medical, prescription drug, dental, and vision coverage
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