About the Role:
The Research Associate will be responsible for supporting the development, validation, and documentation of In Vitro Diagnostic (IVD) real-time PCR products. The role involves hands-on laboratory work, preparation of regulatory and technical documentation, validation reporting, and inventory management using SAP. The position reports directly to the R&D department and plays a key role in product development and commercialization.
Requirements:
Assay Development & Optimization: Support design, development, and optimization of real-time PCR–based IVD assays, including primer/probe evaluation and performance testing.
Validation & Performance Studies: Conduct analytical and clinical validation studies (sensitivity, specificity, precision, reproducibility) and maintain accurate experimental records.
Documentation & Regulatory Compliance: Prepare and maintain D&D documents, SOPs, validation reports, and technical files in line with ISO 13485 and regulatory requirements.
Inventory & Laboratory Management: Manage R&D inventory using SAP, maintain equipment and calibration records, and ensure compliance with GLP, GMP, and biosafety standards.
Cross-Functional Coordination: Collaborate with QA, Production, Regulatory, and Sales teams, support audits, and provide technical troubleshooting when required.
About the Company
NeoDx Biotech Labs is a fast-growing molecular diagnostics company based in Bengaluru, India, focused on designing, developing, and manufacturing advanced in-vitro diagnostic (IVD) solutions. Since our inception in 2020, we have been committed to delivering reliable, affordable, and accessible diagnostic technologies for infectious diseases, oncology, and genetic disorders.
With a strong foundation in bioinformatics and RT-PCR innovation, NeoDx empowers laboratories, hospitals, and research institutions with high-quality diagnostic kits and end-to-end solutions. Our ISO 13485-certified processes ensure precision, compliance, and consistency across all our products.
At NeoDx, we are driven by innovation, collaboration, and a shared mission to improve healthcare outcomes through faster, smarter, and more accessible diagnostics—making a meaningful impact across India and global markets.