Senior Scientist, Process Development (Biologics)
Initial Therapeutics, Inc.
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Benefits offered by this job
Job summary
Amgen is seeking a Process Development Senior Scientist in Cambridge, MA to join the Biologics Pivotal Attribute Sciences team. You will develop and transfer analytical methods, lead protein characterization, and drive automation-ready workflows while supporting regulatory submissions for INDs/BLAs.
The role emphasizes cross-functional collaboration and data-driven decision making. Ideal candidates have a doctorate with strong analytical biology expertise, and experience in chromatographic and
Qualifications
- PhD or equivalent required with strong analytical biology background.
- Experience in analytical method development for biologics and CMC support.
- Ability to author/regulatory submissions for INDs/BLAs.
Responsibilities
- Develop, optimize, and transfer analytical methods for CQAs and process characterization.
- Lead late-stage protein characterization and mass spectrometry analyses.
- Create robust, automation-ready workflows to improve lab efficiency.
- Interpret complex data and draft technical/regulatory documents for INDs/BLAs.
- Provide SME guidance to cross-functional partners.
Skills
Education
Tools
Job description
Amgen is seeking a Process Development Senior Scientist in Cambridge, MA to join the Biologics Pivotal Attribute Sciences team. You will develop and transfer analytical methods, lead protein characterization, and drive automation-ready workflows while supporting regulatory submissions for INDs/BLAs.
The role emphasizes cross-functional collaboration and data-driven decision making. Ideal candidates have a doctorate with strong analytical biology expertise, and experience in chromatographic and
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