AGM - RandD Biochemistry Reagents

Michael Page; Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Michael Page client is seeking a senior R&D leader to drive development of Clinical Chemistry reagents and ITA from concept to commercialization in a fast-growing diagnostics environment. You will mentor scientific teams, manage cross-functional projects and ensure regulatory readiness.

You will partner with Manufacturing, Quality, Regulatory, Marketing and Commercial teams to deliver robust, scalable assays and technology transfers, shaping the product roadmap and future innovations.

Qualifications

• Ph.D. or MSc in Biochemistry, Biotechnology, Life Sciences, Chemistry or a related discipline.
• 15-18 years of experience within the Diagnostics or IVD industry.
• Proven expertise in Clinical Chemistry Reagent Development.
• Strong hands-on experience in Immunoturbidimetric Assays (ITA).
• Deep understanding of assay development, optimisation, validation & troubleshooting.
• Experience in technology transfer, manufacturing scale-up and commercialisation.
• Strong knowledge of reagent chemistry, analytical validation and diagnostic assay development.
• Familiarity with regulatory requirements, ISO standards and quality management systems.
• Demonstrated leadership experience managing scientific teams and cross-functional stakeholders.
• Experience working with fully automated Clinical Chemistry Analysers is highly preferred.

Responsibilities

• Lead end-to-end development of Clinical Chemistry Reagents and diagnostic assays.
• Drive innovation initiatives and identify new product opportunities based on market requirements.
• Develop, optimise and validate Clinical Chemistry and Immunoturbidimetric Assays (ITA).
• Conduct analytical studies, performance evaluations and troubleshooting activities.
• Ensure reagent compatibility across automated Clinical Chemistry Analyser platforms.
• Lead technology transfer activities from R&D to Manufacturing and support scale-up.
• Prepare technical and validation documentation for regulatory submissions.
• Collaborate closely with Manufacturing, Quality, Regulatory, Marketing and Commercial teams.
• Manage product development timelines and ensure successful delivery of project milestones.
• Mentor and develop scientific teams while fostering a culture of innovation and continuous improvement.

Education

Ph.D. or MSc in Biochemistry/ Biotechnology/ Life Sciences/ Chemistry

Tools

Automated Clinical Chemistry Analyzers

Job description

Job Description:

• Lead innovation in clinical diagnostics R&D
• Drive products from concept to commercialisation

About Our Client

Our client is a recognised leader in the diagnostics and healthcare sector, known for its commitment to innovation, scientific excellence and quality-driven product development. With a strong focus on research, technology and commercial growth, the organisation continues to expand its portfolio of diagnostic solutions to meet evolving healthcare needs worldwide.

Job Description

• Lead end-to-end development of Clinical Chemistry Reagents and diagnostic assays.
• Drive innovation initiatives and identify new product opportunities based on market requirements.
• Develop, optimise and validate Clinical Chemistry and Immunoturbidimetric Assays (ITA).
• Conduct analytical studies, performance evaluations and troubleshooting activities.
• Ensure reagent compatibility across automated Clinical Chemistry Analyser platforms.
• Lead technology transfer activities from R&D to Manufacturing and support scale‑up.
• Prepare technical and validation documentation for regulatory submissions.
• Collaborate closely with Manufacturing, Quality, Regulatory, Marketing and Commercial teams.
• Manage product development timelines and ensure successful delivery of project milestones.
• Mentor and develop scientific teams while fostering a culture of innovation and continuous improvement.

The Successful Applicant

• Ph.D. or M.Sc. in Biochemistry, Biotechnology, Life Sciences, Chemistry or a related discipline.
• 15-18 years of experience within the Diagnostics or IVD industry.
• Proven expertise in Clinical Chemistry Reagent Development.
• Strong hands‑on experience in Immunoturbidimetric Assays (ITA).
• Deep understanding of assay development, optimisation, validation & troubleshooting.
• Experience in technology transfer, manufacturing scale‑up and commercialisation.
• Strong knowledge of reagent chemistry, analytical validation and diagnostic assay development.
• Familiarity with regulatory requirements, ISO standards and quality management systems.
• Demonstrated leadership experience managing scientific teams and cross-functional stakeholders.
• Experience working with fully automated Clinical Chemistry Analysers is highly preferred.

What's on Offer

• Opportunity to lead strategic R&D programmes with significant business impact.
• Influence the future product roadmap of a growing diagnostics organisation.
• High-visibility leadership role within a research-driven environment.
• Exposure to cutting-edge diagnostic technologies and innovation initiatives.
• Attractive compensation and long-term career growth opportunities.
• Collaborative culture that values scientific excellence, quality and continuous improvement.