R&D Scientist/Engineer – Reagents

Job Title: R&D Scientist / Engineer – Reagents (Clinical Chemistry, ABG, FIA, CLIA)
Location: Hyderabad, India
Department: Research & Development – Diagnostics
Experience: 2–8 years (level mapped to seniority; freshers with M.Sc/PhD considered for junior roles)
Employment Type: Full-time, on-site
 

About Arni Medica
Arni Medica Private Limited is an ISO 13485:2016 and ISO 9001:2015 certified medical device and in-vitro diagnostics (IVD) manufacturer based at the Medical Devices Park, Sangareddy (Hyderabad), Telangana. We design and manufacture nephrology, infusion therapy, respiratory care and surgical disposables, and are building a full IVD diagnostics franchise spanning clinical chemistry, electrolyte/ISE, blood gas (ABG), fluorescence immunoassay (FIA) and chemiluminescence immunoassay (CLIA) platforms — backed by Class 100K/10K cleanrooms, EtO sterilization and a CDSCO manufacturing licence (MFG/MD/2023/000942).
 

Role Overview
We are seeking an R&D Scientist/Engineer to develop, optimise, validate and transfer reagent formulations for our Electrolyte/ISE, ABG, FIA and CLIA platforms, with strong emphasis on analytical performance, stability and manufacturability. You will drive both new product development and continuous improvement of existing products while owning design-control documentation.
 

Key Responsibilities

• Design, develop, formulate and optimise IVD reagents, calibrators, controls, buffers, conjugates and consumables across diagnostic platforms.
• Develop assays across Clinical Chemistry (GOD-POD, Jaffe/enzymatic creatinine, CHOD-PAP lipids, turbidimetric CRP), ISE/electrolyte, ABG, FIA and CLIA.
• Conduct design of experiments (DoE), stability studies (real-time/accelerated), forced degradation, interference and performance characterisation.
• Establish analytical performance — accuracy, precision, linearity, LoB/LoD/LoQ and method comparison — per CLSI guidelines (EP05/EP06/EP09/EP25).
• Author DHF / design-control documentation, verification & validation protocols, development reports, transfer documents and manufacturing instructions.
• Lead reagent technology transfer R&D → manufacturing: scale-up, specification setting and lot-to-lot consistency studies.
• Support complaint investigations, CAPA and product-performance troubleshooting with QA, QC, RA and Production.

Desired Candidate Profile

Education: M.Sc / PhD in Biochemistry, Biotechnology, Microbiology, Chemistry or Immunology; or B.Tech/M.Tech in Chemical/Biomedical Engineering. PhD preferred for CLIA/immunoassay roles.

Experience: 2–8 years of hands-on IVD reagent/assay development. Junior (1–4 yrs), Senior/Scientist (4–8 yrs); strong M.Sc/PhD freshers considered for entry roles.

Technical Skills & Keywords

Assay development, reagent formulation, clinical chemistry, immunoassay, CLIA/chemiluminescence, FIA/fluorescence immunoassay, ELISA, ISE/electrolyte, blood gas/ABG, antibody conjugation, enzyme kinetics, calibrators & controls, spectrophotometry, turbidimetry, nephelometry, design verification & validation, CLSI (EP05/EP06/EP09/EP25), stability protocols, ICH, ISO 13485:2016, design control / DHF.

Preferred / Good to Have

• Specific platform match — CLIA, FIA or ABG reagent development.
• Antibody / conjugate chemistry and tech-transfer experience.
• CDSCO MDR 2017 / ISO 13485 design-control documentation exposure.

What We Offer

• A rare opportunity to help build a greenfield IVD diagnostics business from the ground up.
• Modern, ISO 13485 / CDSCO-compliant manufacturing environment with cleanroom infrastructure.
• Direct collaboration with R&D, Regulatory and senior leadership — visible impact, fast decisions.
• Competitive compensation, commensurate with experience (negotiable; as per industry standards).
• Accelerated career growth in a fast-scaling, export-oriented MedTech company.
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