Formulation & Process Development Scientist - Protein Drugs
BioSpace
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Job summary
Amgen in Thousand Oaks is seeking an experienced Process Development Associate Scientist to contribute to early-stage portfolio projects across therapeutic modalities, focusing on formulation development and stability characterization of large molecule candidates. You will help advance drug products through development with rigorous data collection and cross-functional collaboration.
The role requires hands-on formulation experience, knowledge of quality systems, and strong communication to
Qualifications
- Masters degree or equivalent in a relevant field; multiple qualification paths described in the posting.
- Experience in pharmaceutical/biotech stability and formulation development is required.
- Strong analytical and data interpretation skills; proficient in scientific documentation.
Responsibilities
- Plan, execute, and document stability studies for FIH formulations and fill/finish processes.
- Design in-use compatibility studies for clinical dose preparation and administration.
- Conduct stability assessments for liquid and lyophilized formulations using appropriate analytical methods.
- Develop multi-modality protein formulations and perform analytical characterization (HPLC/UPLC, MS, CE, biophysical tools).
- Collaborate in cross-functional teams and contribute to IND-related documentation.
Skills
Education
Tools
Job description
Amgen in Thousand Oaks is seeking an experienced Process Development Associate Scientist to contribute to early-stage portfolio projects across therapeutic modalities, focusing on formulation development and stability characterization of large molecule candidates. You will help advance drug products through development with rigorous data collection and cross-functional collaboration.
The role requires hands-on formulation experience, knowledge of quality systems, and strong communication to
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