Job Description

We are Hiring!!
Job Title: Research Associate / Scientist – Diagnostic Kit Development
Experience: 2–3 years
Location: Bangalore

About the Role:
We are seeking a motivated and skilled scientist with hands-on experience in developing rapid diagnostic kits, including Lateral Flow Assays (LFA), Dip stick assay and Loop-Mediated Isothermal Amplification (LAMP)-based assays. The candidate will also support test licensing processes, CDSCO applications, and ISO 13485, GMP compliance, playing a critical role in bringing point-of-care diagnostics from lab to market.

Key Responsibilities:
Assay Development:
Design, develop, and optimize LFAs and LAMP-based molecular assays.
Perform nanoparticle conjugation, strip assembly, blocking optimization, and nucleic acid amplification optimization.
Conduct validation studies for sensitivity, specificity, reproducibility, stability, and cross-reactivity.
Regulatory & Licensing:
Prepare and support applications for test licenses (Form MD-12/MD-13 as applicable).
Assist in documentation for CDSCO submissions and other regulatory authorities.
Ensure compliance with GMP and ISO 13485 standards during product development.
Coordinate with QA/RA teams for regulatory dossiers, validation reports, and technical files.
Technology Transfer & Scale-up:
Work with cross-functional teams to transfer assays from R&D to manufacturing.
Draft SOPs, batch records, and QC protocols for production.
Support audit preparation and compliance with quality management systems.

General:
Maintain proper documentation and records in line with regulatory standards.
Collaborate with internal teams and external agencies to ensure smooth licensing and scale-up.
Required Qualifications & Skills:
Master’s degree in Biotechnology, Biochemistry, Molecular Biology, or related field.
2–3 years of experience in developing LFAs, rapid diagnostic kits, or nucleic acid iso-thermal amplification-based assays.
Hands-on expertise in immunoassays, antibody/antigen interactions, nucleic acid amplification, and nanoparticle conjugation.
Familiarity with LAMP primer design, detection formats (colorimetric, fluorescence, turbidity, etc.), and assay optimization.
Experience with test license application processes, CDSCO submissions, and regulatory documentation.
Knowledge of GMP, ISO 13485, and IVD product development standards.
Strong troubleshooting and problem-solving skills.

Preferred Attributes:
Prior experience with diagnostic kit licensing and CDSCO interactions.
Exposure to regulatory submissions, audits, and product commercialization.
Strong documentation, organizational, and communication skills.
Ability to work in a fast-paced, startup environment with cross-disciplinary teams.

Interested candidates reach out to Email: tanulifesciences@gmail.com
or WhatsApp to: +91 9632189056