Sr Associate Scientist, Analytical Ops
About The Position
We are seeking a Senior Associate Scientist to join Analytical Development, where you will develop, optimize, qualify, and transfer potency assays supporting characterization and lot release testing for cell and gene therapy programs. You will bring hands-on expertise in flow cytometry and immunoassay platforms (ELISA and ProteinSimple Ella) to build robust, phase-appropriate methods with well-defined controls, standards, and acceptance criteria. You will collaborate closely with Process Development, QC, Manufacturing, and Quality to ensure methods are transferable, compliant, and inspection-ready, with strong documentation practices and data integrity expectations. The successful candidate will bring strong hands-on experience with flow cytometry and immunoassay platforms (ELISA and ProteinSimple Ella) and a solid understanding of potency strategy, assay controls/standards, and data quality. While this role sits in Analytical Development, it requires a strong QC mindset: designing assays that are robust, transferable, and inspection-ready, with clear system suitability, acceptance criteria, and compliant documentation. You will partner closely with Process Development, QC, and Quality to ensure methods are phase-appropriate and can be executed reproducibly for characterization and lot release.
Requirements
- BS in Biochemistry, Molecular Biology, Analytical Chemistry, or a related discipline with 8+ years of relevant industry experience, or MS with 6+ years
- Demonstrated expertise in flow cytometry and immunoassays, including ELISA and ProteinSimple Ella (or similar automated immunoassay platforms)
- Experience developing, qualifying, and troubleshooting potency assays (including cell-based functional assays) for biologics, cell therapy, and/or gene therapy programs
- Proven experience authoring and executing assay qualification/validation plans and reports in alignment with ICH Q2 principles and internal quality standards
- Familiarity with QbD concepts for analytical methods (e.g., defining assay intent, critical method parameters, robustness/ruggedness, control strategy) and relevant ICH and health authority expectations for potency methods across development stages
- Prior experience in a QC environment and/or strong QC-facing Analytical Development experience (e.g., method transfer, release testing support, controlled documentation, deviations/OOS investigations)
- Working knowledge of potency assay considerations (e.g., reference standards, system suitability, controls, assay drift) and phase-appropriate CMC expectations
- Understanding of data integrity expectations (ALCOA+) and experience working within GxP quality systems (e.g., controlled documents, training, change control, deviation management)
- Proficiency in data analysis and visualization using tools such as FlowJo (or equivalent) and JMP; able to perform trending and summarize assay performance
- Excellent technical writing skills for protocols, reports, and submissions
- Strong collaborative mindset and communication skills
- Comfortable operating in a QC-style environment (right-first-time execution, schedule-driven deliverables, rigorous documentation, and adherence to approved procedures)
Responsibilities
- Develop, optimize, and qualify potency assays to support product characterization, process development, and lot release for cell and gene therapy programs
- Design and execute flow cytometry–based assays (e.g., phenotyping, receptor/ligand binding, functional readouts) including panel design, instrument setup, and gating strategy development
- Develop and run immunoassays (ELISA and Ella) to measure potency-relevant analytes (e.g., cytokines, activation markers, soluble ligands) and support assay lifecycle management
- Perform cell-based functional potency assays (as applicable) including assay setup, reagent qualification, acceptance criteria, and troubleshooting of performance issues
- Plan and execute assay qualification/validation studies (e.g., accuracy, precision, linearity, range, specificity, robustness) aligned with ICH/USP guidance and phase-appropriate requirements
- Troubleshoot assay performance (flow, ELISA, Ella, and cell-based assays) and drive continuous improvements to robustness, throughput, and data integrity
- Collaborate cross-functionally with Process Development, QC, Quality, and Manufacturing to align on potency strategy, define assay requirements, and support method transfer activities
- Establish QC-ready assay elements (reference standards/controls, system suitability, plate/run layouts, acceptance criteria) and ensure methods are fit-for-purpose, rugged, and transferable
- Author and review protocols, technical reports, and SOPs in accordance with GDP/GMP expectations; ensure traceable documentation and alignment with internal quality systems
- Perform data trending and monitoring (e.g., control charts, OOT signals, reagent lots) and partner with QC/Quality on assay lifecycle activities such as change control, reagent qualification, and method updates
- Support QC investigations (deviations, OOS/OOT) by providing technical assessment, experimental follow-up, and clear documentation; contribute to CAPA and risk assessments as needed
- Maintain compliance with GMP and internal quality systems; support deviations, investigations, and inspection readiness as needed
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
501-1,000 employees
