Scientist, Reagent and Assay Development
$40 - $42 per hourFull-time
Healthcare
Roles & 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
- Provide technical support 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 Operation teams to support business objectives
Experience Required
- Minimum of bachelor’s degree in Life Science
- Minimum 2 years of related experience in a research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment
Skills & Certifications
- Demonstrated ability to collaborate effectively across functions
- Excellent written and verbal communication skills
Eligibilities & qualifications
- Minimum of bachelor’s degree in Life Science
- Minimum 2 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 collaborate effectively across functions
- Excellent written and verbal 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
Vacancy posted 1 day ago
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