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Senior Biochemistry Development Scientist
2 weeks ago
About Vitalbio
We are a leading company in the development of diagnostic products, and we are seeking a highly skilled Research Scientist to join our team.
Job Summary
The Research Scientist will be responsible for developing, optimizing, and validating new assays for our diagnostic product pipeline. This role requires strong scientific expertise, excellent communication skills, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities
- Assay Development: Develop, optimize, and validate new assays for our diagnostic product pipeline, ensuring high-quality results and compliance with regulatory requirements.
- Laboratory Operations: Construct, modify, and follow standard operating procedures in direct collaboration with the development team, ensuring seamless laboratory operations and efficient workflow.
- Team Collaboration: Work closely with the development team to achieve project goals, contributing to departmental strategies and providing input on laboratory requirements and improvements.
- Quality Management: Ensure all development work is well-documented and follows Vitalbio's quality processes and procedures, collaborating with QMS to maintain high-quality standards.
- Standard Operating Procedures: Author, review, and hone standard operating procedures (SOPs) to improve quality and accelerate our assay pipeline.
- Interdisciplinary Collaboration: Partner closely with research, manufacturing science, downstream formulation, and engineering teams to provide assay development support and ensure performance requirements are met.
Requirements
- Educational Background: MSc or PhD degree in biochemistry, biology, immunology, hematology, or a related field, with a minimum of 3 years of hands-on laboratory experience in industry.
- Experimental Execution: Proven experience in executing experiments in a wet lab, preferably in an industry setting, with a strong understanding of laboratory automation/liquid handling systems.
- Regulatory Compliance: Experience with verification and validation of assays through regulatory agencies like the FDA, Health Canada, or EU, with knowledge of associated regulatory pathways.
- GMP Experience: GMP experience will be considered an asset, as will familiarity with the medical device industry and its associated regulations.
- Assay Development: Experience in developing and optimizing assays with clinical samples, with a focus on delivering high-quality results and improving laboratory efficiency.