R&D Scientist/Engineer – Reagents

Arni Medica Pvt Ltd.; Hinoba-an; On-site; PHP 591,000 - 986,000; Full time

Benefits offered by this job

Greenfield project

ISO 13485 environment

Direct leadership access

Career growth

Job summary

Arni Medica Private Limited is seeking an R&D Scientist/Engineer to develop and optimize reagent formulations for ABG, FIA and CLIA platforms. You will own analytical performance, stability, and manufacturability while driving design‑control documentation and technology transfer from R&D to production.

Ideal candidates have 2–8 years in IVD reagent development, with MSc/PhD supporting CLIA/immunoassay roles.

Qualifications

• MSc/PhD preferred for CLIA/immunoassay roles.
• 2–8 years of hands‑on IVD reagent/assay development.
• Experience in developing assays across Clinical Chemistry, ISE, ABG, FIA and CLIA.

Responsibilities

• Design, develop, formulate and optimise IVD reagents, calibrators, controls, buffers and conjugates across diagnostic platforms.
• Develop assays across Clinical Chemistry, ISE, ABG, FIA and CLIA.
• Conduct DoE, stability studies, forced degradation and performance characterisation.
• Establish analytical performance per CLSI guidelines (EP05/EP06/EP09/EP25).
• Author DHF / design‑control documentation, verification & validation protocols, development reports and manufacturing instructions.
• Lead reagent technology transfer from R&D to manufacturing with scale‑up and lot‑to‑lot studies.
• Support complaint investigations, CAPA and product‑performance troubleshooting with QA/QC/RA.

Skills

Assay development

Reagent formulation

Clinical chemistry

Immunoassay

CLIA/chemiluminescence

FIA/fluorescence immunoassay

ISE/electrolyte

Quality documentation

Analytical methods

DoE

Education

MSc/PhD in Biochemistry/Biotechnology/Microbiology/Chemistry/Immunology

BTech/MTech in Chemical/Biomedical Engineering

Job description

Patancheru, India | Posted on 08/27/2026

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.

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.

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.