R&D Scientist/Engineer – Reagents

Arni Medica Pvt Ltd.; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Career growth opportunities

Competitive compensation

Export-oriented MedTech environment

Job summary

Arni Medica Private Limited is seeking an R&D Scientist/Engineer to develop and optimize IVD reagents for electrolyte/ISE, ABG, FIA and CLIA platforms. You will drive new product development and continuous improvement, owning design-control documentation and transfer to manufacturing.

The role demands 2–8 years of hands-on reagent/assay development with a strong background in analytical method validation, stability studies, and CLSI guidelines.

Qualifications

• Hands-on IVD reagent/assay development experience.
• Experience in design-control documentation and DHF/validation.
• Strong knowledge of CLSI guidelines and stability protocols.

Responsibilities

• Design, develop, formulate and optimise IVD reagents, calibrators, controls and buffers across platforms.
• Develop assays for Clinical Chemistry, ISE, ABG, FIA and CLIA.
• Conduct DoE, stability, forced degradation and performance evaluations.
• Establish analytical performance (accuracy, precision, linearity, LoB/LoD/LoQ) per CLSI.

Skills

Assay development

Reagent formulation

Analytical method validation

DoE (Design of Experiments)

Platform knowledge: CLIA/FIA/ABG

Stability studies

Documentation & DHF

Education

M.Sc in Biochemistry/ Biotechnology/ Microbiology/ Chemistry

PhD in related field

B.Tech / M.Tech in Chemical/Biomedical Engineering

Job description

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.

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.