Experience
2 - 8 yrs
Job Location
India
Vacancy
1
Designation
R&D Scientist
Job Type
Not specified
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
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).
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.
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.
- 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.