Process Development Sr Principal Scientist
Amgen · Thousand Oaks, CA
The apply link worked recently (not employer-confirmed).
Role summary
Lead analytical sciences for late-phase oligonucleotide programs at this biotech manufacturer, overseeing method development, validation, and control strategy implementation through commercialization. Manage a team of analysts supporting process development across synthetic small molecules, peptides, and SiRNA manufacturing while collaborating cross-functionally on regulatory submissions and commercial launch activities.
What they're looking for
- PhD in analytical, organic, physical chemistry, pharmaceutical sciences, or related field
- Pharma or biotech industry experience in process development and analytical method development
- Hands-on expertise in small molecule, peptide, and oligonucleotide analysis and characterization
- Proficiency with analytical techniques: mass spectrometry, NMR, FTIR, UV, and structure elucidation
- Experience with method validation, transfer, and GMP/GLP requirements
- Strong technical writing and cross-functional communication abilities
- Knowledge of ICH/FDA guidance and USP monographs for analytical methods
What you'll be doing
- Lead analytical scientists team developing and validating methods for oligonucleotide programs through commercialization
- Establish analytical control strategies and characterize critical quality attributes for late-phase clinical programs
- Mentor team members and guide career development within the analytical sciences group
- Collaborate with process development, manufacturing, and regulatory teams to resolve technical challenges
- Author technical reports and CMC sections for regulatory submissions and address health authority inquiries
Privacy & handoff
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