Senior Scientist, In-Vitro Diagnostics Expert
1 month ago
We are seeking a highly skilled Senior Scientist to join our team as a Technical Lead for In-Vitro Diagnostic Product Development. As a key member of our R&D team, you will be responsible for leading the design and development of new In-Vitro Diagnostic technologies from initial concept creation through in-house verification and into clinical validation.
Key Responsibilities- Develop and implement a clear implementation pathway that aligns development strategy and company priorities, including attention to and monitoring of timelines.
- Develop design inputs based on solid scientific research and exploration into region-specific regulatory requirements.
- Lead the design, development, and clinical validation of assay-specific reagent kits, reagent and reagent formulation, control development, and test optimization.
- Oversight of day-to-day lab work with the team to effectively and efficiently drive timely milestone achievement.
- Lead by example, providing leadership within the Scientific Affairs Team and Company, including product development planning and execution, quality, regulatory compliance, technical support, and issue resolution.
- MS or PhD in a related field, Minimum of 5-7 years of industry experience.
- Direct product development experience of rapid IVD devices with successful commercialization experience is highly valued.
- Broad scientific knowledge and strong critical thinking skills, excellent attention to detail, including accurate and thorough record keeping, technical report writing, experience in clinical test development in a clinical research environment, and the ability to anticipate, recognize, and resolve technical problems.
BioLytical is a rapidly growing biomedical company dedicated to developing innovative rapid diagnostic tests to help fight several diseases around the world. We are committed to being vertically integrated, producing in-house all the materials required for the testing device, from recombinant protein production to the final kit.
Our Core Values- INNOVATION: Contributes new ideas, challenges the status quo, takes the initiative on projects.
- NEVER SAY NEVER: Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
- SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
- TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
- INSPIRED to excel: Demonstrates a passion for INSTI, our people, and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
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