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 https://jobeax.com/link/dG8yP0JQtNcQufc1 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: https://jobeax.com/link/MPrGoo1PSJpZ7d0e / PhD in Biochemistry, Biotechnology, Microbiology, Chemistry or Immunology; or https://jobeax.com/link/yZvtq40aJzRI3Eg6 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 https://jobeax.com/link/dG8yP0JQtNcQufc1 freshers considered for entry roles.

T echnical 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.

R&D Scientist/Engineer - Reagents

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