Scientist I Analytical Development
Overview
Scientist I leads Functional Flow Cytometry and BioAnalytics team to establish and develop analytical methods for cell and gene therapy pipeline. This laboratory-focused role requires developing, optimizing, and qualifying methods for viral vector and CAR-T product characterization. Candidate will author and review methods, maintain electronic lab notebooks, and collaborate across functional teams.
What You'll Do12
- 1Develop, optimize, and execute analytical methods for viral vector and CAR-T product characterization including compendial methods, titer, particle size, flow cytometry, and cell-based potency methods
- 2Author and review methods protocols and reports
- 3Maintain reagent inventory and order materials as needed
- 4Generate and qualify critical materials for analytical methods
- 5Observe laboratory safety standards including PPE use and BSL2 best practices
- 6Perform pre-qualification assay qualification product release testing and product characterization testing
- 7Transfer methods to QC and external collaborators while receiving methods from internal and external sources
- 8Maintain contemporaneous electronic laboratory records following ALCOA+ standards
- 9Perform peer review and data integrity reviews in analytical development and quality control environments
- 10Collaborate cross-functionally with PD QC and Manufacturing teams for assay execution troubleshooting and continuous improvement
- 11Present scientific data at internal and external forums
- 12Balance multiple projects while meeting established timelines
Requirements9
- 1Bachelor's degree in a related field with 5 or more years of relevant experience or Master's degree with 3-5 years or PhD with 0-2 years
- 2Strong laboratory background including flow cytometry mammalian cell culture ELISA and cell-based assays
- 3Experience implementing compendial methods preferred
- 4Experience with lentiviral vector characterization including infectious titer potency and transduction efficacy assays
- 5Solid understanding of ICH guidelines and regulatory expectations for method qualification
- 6Experience with assay qualification release testing and product characterization testing in regulated environments
- 7Proficiency with document change management and document review/approval workflows
- 8Detail-oriented problem solver with excellent verbal and written communication skills
- 9Expertise with GraphPad Prism PowerBI JUMP R CytoExpert FCS express FlowJo ELN LabVantage
Salary Insight
$96 - $126k per year
Location
Required Skills
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