Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Control – Product Lead
Organon
Associate Principal Scientist, Regulatory Affairs, Chemistry, Manufacturing, and Control
Organon
full-time
Posted on:
Location Type: Hybrid
Location: Jersey City • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyCMC submission componentsbiological researchpharmaceutical researchmanufacturingtestingquality assuranceanalytical skills
Soft skills
leadershipcollaborationcommunicationcritical revieworal communicationwritten communication
Certifications
Bachelor’s degreeMSMBAPh.D.PharmD
