Principal Scientist leading CDx/IVD development projects in Translational Oncology within a leading health care company. Collaborating with teams on diagnostics and biomarker strategies.
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Hybrid Associate Principal Scientist, Regulatory Affairs, Chemistry, Manufacturing, and Control
Posted 4 months ago
About the role
- Associate Principal Scientist responsible for developing regulatory CMC strategies for small molecule products in women's health at Organon. Leading CMC dossier preparation and submission for global operations.
Responsibilities
- Serve as the CMC Product Lead for assigned products
- 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 for product in-license/due diligence review
- Collaborate with Organon Manufacturing & Supply colleagues and external partners
Requirements
- Bachelor’s degree in a science, engineering, or a related field
- At least seven years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) with at least four years of relevant experience
- Proficient in English; additional language skills are a plus
- Proven experience in critically reviewing detailed scientific information
- Demonstrated superior oral and written communication skills
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance)
Benefits
- Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
- Paid caregiver/parental and medical leave
- Paid vacation and holiday time
- Retirement savings plan
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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