Senior Scientist, Reagent and Assay Development
Job Description
Job Description
Pay Range: $51.52hr - $56.52hr
Job Overview:
The Reagent & Assay Development Group focuses on providing differentiated reagent solutions that uncover truths in biology and medicine. Teams of dedicated scientists are responsible for initiating and driving the reagent and assay development projects and integrating assays and flow cytometry instruments to create the next generation of research and clinical flow cytometry platforms. Products include cell analyzers, cell sorters, reagents, assays, and software. The Scientist III is responsible for supporting the sustainment and continuous improvement of reagent and assay products throughout their lifecycle.
Primary Responsibilities:
- Support reagent and assay sustainment projects for marketed products.
- Review and approve technical documentation to support reagent and assay products.
- Review design history files, validation reports, risk assessments, technical files, and product specifications to ensure 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 preparation of 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.
Minimum Qualifications:
- Minimum of a bachelor's degree in Life Science.
- Minimum of 5 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/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.
Desired Qualifications:
- Experience with flow cytometry-based diagnostic products.
- Experience supporting regulatory inspections and quality audits.
- Familiarity with design controls, risk management, verification/validation, and change control processes.
- Strong immunology, cancer biology, and cell biology knowledge.
- Experience in reagent and assay development.
- Experience with product lifecycle management.
Benefits:
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.