ShanX Medtech BV (SXM, NL) is a dynamic young company dedicated to revolutionizing healthcare through innovative diagnostic tools. Our journey began with a deeply personal experience—the founder's mother's near-fatal struggle with a poorly treated bacterial infection. This ignited our mission to transform infection management, propelling us to develop pioneering solutions that prevent unnecessary suffering.
At SXM, impact is paramount. We're proud to introduce KAIROS IVD, our groundbreaking rapid antibiotic susceptibility testing device, poised to redefine how bacterial infections are treated. Our goal is clear: to equip healthcare professionals with the means to make informed treatment decisions swiftly and accurately. Through our innovative solutions, we're combating antibiotic resistance, enhancing patient outcomes, and saving lives.
As an IVD Assay Developer at SXM you will be responsible for the development and optimization of our diagnostic assays for future commercialization. The role of the IVD Assay Developer is crucial in driving assay development efforts, optimizing assay performance, and laying the groundwork for future commercialization and regulatory approval of diagnostic products.
This is a full-time contract for 40 hours per week, extending over three years, with the possibility of extension.
Tasks
Your responsibilities include, but are not limited to:
Assay Development: Crafting and refining our current and future diagnostic
assays.
Optimization: Enhancing assay performance parameters such as sensitivity,
specificity, capability and reproducibility through iterative experimentation. This
includes identifying and refining assay protocols and formulations to achieve
optimal results.
Validation: Conducting validation studies to assess the analytical and clinical
performance of diagnostic assays. This involves testing assay performance with
clinical samples and analyzing data to demonstrate accuracy and precision.
Documentation: Thoroughly documenting all aspects of assay development,
including experimental protocols, results, and findings. This meticulous recordkeeping
will be used for regulatory submissions and intellectual property
protection.
Regulatory Compliance: Ensuring adherence to regulatory requirements
governing diagnostic assay development. This includes compliance with FDA
regulations and ISO standards.
Quality Assurance: Implementing quality control measures to uphold the
reliability and consistency of our diagnostic assays. Adherence to standard
operating procedures and quality management systems ensures high-quality
standards are maintained.
Requirements
- Required qualifications:
• Master’s degree in biology, Microbiology, Biomedical Engineering, or a related field with a preference in Biochemistry.
• Minimally 3 years’ experience in a relevant position in an IVD company, having developed IVD assays that received IVDR approval.
• Past assay development according to regulatory requirements and standards relevant to the FDA regulations, ISO standards, and Good Laboratory Practices (GLP). Ability to work according to quality management systems.
• Fluency in English.
• Strong analytical and problem-solving skills with attention to detail.
- Preferred qualifications:
• Flexibility and adaptability to work in a dynamic and fast-paced environment with evolving priorities and timelines.
• A passion for innovation and a creative, out-of-the-box mindset are highly valued.
• Passionate about working in a young IVD company.
• Commitment to continuous learning and professional development to enhance skills and knowledge in assay development, rapid Antibiotic Susceptibility Testing (AST)
diagnostics, and related areas.
Benefits
• Competitive compensation and benefits package
• Access to professional development opportunities for career growth and
advancement, including training resources.
• Flexible schedule and work arrangements
• Dynamic and collaborative work environment
Join us in shaping the future of healthcare, where every moment is vital in the fight against bacterial infections. We're seeking a motivated IVD Assay Developer to join our team and contribute to the development of this crucial diagnostic device. This is an exceptional opportunity to join us in our early stages and play a pivotal role in our future success.