Machine Learning Research Scientist conducting applied AI/ML research at SEI. Developing prototype capabilities for government workflows with a focus on mission context.
SI
Hybrid Associate Principal Scientist, Regulatory Affairs, Chemistry Manufacturing & Controls
Posted 5 months ago
About the role
- Associate Principal Scientist leading Regulatory CMC strategies for small molecule and biological products. Ensuring compliance with global regulations while driving product lifecycles in pharmaceutical industry.
Responsibilities
- 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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