Principal Research Scientist — Injectable Drug-Device Lead
CHEMICAL & INDUSTRIAL ENGINEERING
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Benefits offered by this job
Job summary
Yoh is seeking a Principal Research Scientist in Westfield, Indiana. The role focuses on analytical development and formulation of injectable biologics, with responsibilities spanning from bench work to regulatory documentation for IND/BLA submissions.
The ideal candidate has a strong background in pharmaceutical sciences, 10 years of experience in pharma/biotech, and hands-on experience with drug-device combination products under design controls.
Qualifications
- Master's degree required.
- 10 years of progressive industrial experience in pharma/biotech with late-stage deliverables.
- Experience developing and evaluating drug-device combination products under design controls.
Responsibilities
- Characterize biologic molecules using advanced techniques to monitor stability and degradation pathways.
- Design and execute formulation strategies for liquid parenteral drug products.
- Participate in the technical integration of injectable formulations with device delivery systems.
- Train/Mentor junior scientists, lead matrixed project teams, and collaborate with Device, Quality, and Regulatory teams.
- Scale-up and transfer of drug product manufacturing processes to clinical and commercial CMO/CDMO sites.
- Author and review technical reports, protocols, patents, and CMC modules for IND/BLA submissions.
Education
Job description
Yoh is seeking a Principal Research Scientist in Westfield, Indiana. The role focuses on analytical development and formulation of injectable biologics, with responsibilities spanning from bench work to regulatory documentation for IND/BLA submissions.
The ideal candidate has a strong background in pharmaceutical sciences, 10 years of experience in pharma/biotech, and hands-on experience with drug-device combination products under design controls.
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