Process Development Principal Scientist – Drug Product Technologies
Amgen · Thousand Oaks, CA
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Role summary
This Principal Scientist role leads early-stage drug product development for diverse biologics modalities, including antibody-drug conjugates and oligonucleotides. Responsibilities span formulation design, process development, analytical characterization, and regulatory support, with emphasis on cross-functional collaboration in a fast-paced environment. The ideal candidate brings hands-on experience in biologics formulation and process development, with preferred expertise in ADCs or siRNA technologies.
What they're looking for
- Hands-on experience in biologics drug product formulation and process development
- Leadership experience in analytical characterization of complex biologics
- Strong expertise with ADCs and/or oligonucleotides such as siRNAs
- Demonstrated ability to integrate formulation, analytical, stability, and process data
- Experience with critical quality attributes evaluation and regulatory submissions
- Proficiency in high-throughput formulation screening and data-driven tools
- Familiarity with machine learning, AI, and automation in drug development
What you'll be doing
- Lead drug product development teams designing formulations and processes for diverse biologics modalities
- Develop and characterize liquid and lyophilized formulations for ADCs, oligonucleotides, and multispecific molecules
- Evaluate critical quality attributes including aggregation, degradation pathways, and modality-specific parameters
- Collaborate across functional teams to advance programs and communicate technical recommendations to leadership
- Author technical documents, regulatory submissions, and technology transfer packages supporting clinical development
Privacy & handoff
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