Staff Scientist – Senior Manager – Quality Control & Analytical Development
| Company | Glyphic Biotechnologies |
|---|---|
| Location | Berkeley, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Advanced degree in Chemistry, Analytical Chemistry, Biochemistry, or related field
- 8+ years in analytical development or protein characterization with quality control experience
- Proven track record operating and maintaining LCMS, HPLC, CE systems independently
- Deep understanding of separation science, mass spectrometry, spectrophotometry, electrophoresis
- Proficiency in statistical analysis and report generation
- Experience with analytical method development, optimization, validation
- Demonstrated complex troubleshooting (instrument, method, sample prep issues)
- Strong technical writing (SOPs, reports, investigations)
- Proven ability to manage multiple time-sensitive projects supporting cross-functional stakeholders
Responsibilities
- Execute analytical testing using LCMS, HPLC, and CE instruments for protein and nucleic acid characterization and purity assessment
- Establish and operate a new QC & AD core to support instrument and assay development
- Develop, optimize, and validate analytical methods to characterize novel protein sequencing instrumentation and production processes
- Implement and oversee phase-appropriate in-line quality control processes and monitoring programs
- Establish and perform QC testing for raw materials and finished products
- Support investigations for out-of-specification results, including root cause analysis, corrective action implementation, and detailed investigation reports
- Support stability studies and comparability programs
- Establish and maintain a phase-appropriate environmental monitoring program
- Generate quality metrics reports analyzing testing volumes, turnaround times, and trends in analytical results
- Manage QC sample storage, retention, and disposal according to safety protocols, particularly for hazardous materials
- Author and review study protocols and reports as well as documentation to comply with regulatory and audit requirements
Preferred Qualifications
- Proficiency in Agilent BioConfirm software
- Proficiency in Atlassian tools for project management
Benefits
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No information provided on Benefits.