Senior Assay Development Scientist - Flow Cytometry
About The Position
The Reagent & Assay Development Group develops differentiated reagent solutions that support research in biology and medicine. Its scientists drive reagent and assay development projects, integrating assays with flow cytometry instruments to develop research and clinical platforms. Products include cell analyzers, cell sorters, reagents, assays, and software. The Scientist III supports the sustainment and continuous improvement of reagent and assay products throughout their lifecycle. The role reviews technical documentation, supports change control and audit readiness, and collaborates with cross-functional teams to help ensure product documentation and processes meet quality system requirements and regulatory expectations.
Requirements
- Bachelor's degree in a life science.
- At least 5 years of related experience in a research setting, clinical or diagnostic laboratory, or pharmaceutical or biotechnology R&D environment.
- Strong understanding of immunology, flow cytometry, assay development, or related cell-based research technologies.
- Experience authoring and reviewing technical documentation.
- Demonstrated ability to lead projects independently and collaborate effectively across functions.
- Strong verbal and written communication skills.
Nice To Haves
- Experience with flow cytometry-based diagnostic products.
- Experience supporting regulatory inspections and quality audits.
- Familiarity with design controls, risk management, verification and validation, and change control processes.
- Strong knowledge of immunology, cancer biology, and cell biology.
- Experience in reagent and assay development.
- Experience with product lifecycle management.
Responsibilities
- Support reagent and assay sustainment projects for marketed products.
- Review and approve technical documentation supporting reagent and assay products.
- Review design history files, validation reports, risk assessments, technical files, and product specifications for completeness and compliance.
- Ensure documentation aligns with applicable quality system requirements and regulatory expectations.
- Support change control activities and assess the impact of proposed product, process, or documentation changes.
- Serve as a technical subject matter expert during internal and external audits.
- Support audit-readiness activities and ensure technical documentation is inspection-ready.
- Partner with Regulatory Affairs, Quality, Marketing, Manufacturing, Medical Affairs, and Operations teams to support business objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
