? We're Hiring | Senior Manager – R&D; (Molecular Diagnostics)
? Location: Vapi, Gujarat
? Experience: 5–10 Years
? Qualification: Ph.D. / M.Tech. / M.Sc. in Molecular Biology, Biotechnology, Microbiology, Biochemistry, Genetics, or related Life Sciences
About the Role
We are looking for an experienced Senior Manager – R&D; (Molecular Diagnostics) to lead the development of innovative RT-PCR-based In Vitro Diagnostic (IVD) products. The ideal candidate will drive assay development, validation, regulatory documentation, and product commercialization while leading a high-performing R&D; team.
Key Responsibilities
Lead the development and optimization of qualitative & quantitative RT-PCR assays for IVD applications.
Develop and validate molecular diagnostic assays for open and microfluidic/cartridge-based platforms.
Design and optimize primers, probes, multiplex assays, and RT-PCR workflows.
Prepare and review regulatory documentation, technical files, design verification & validation reports, and risk management files.
Plan and execute analytical performance studies,
including LOD, specificity, precision, reproducibility, and stability.
Ensure compliance with ISO 13485, ISO 14971, and applicable IVD regulatory requirements.
Collaborate with Quality, Regulatory Affairs, Manufacturing, and Product Management teams for successful product development and technology transfer.
Lead, mentor, and manage multiple R&D; projects from concept to commercialization.
Required Skills
Solid hands-on experience in qualitative & quantitative RT-PCR assay development.
Expertise in primer/probe design, multiplex assay development, and qPCR data analysis.
Experience with microfluidic or cartridge-based molecular diagnostic systems is preferred.
Strong knowledge of IVD technical documentation and regulatory dossier preparation.
Excellent project management, scientific writing, problem-solving, and leadership skills.
If you are passionate about advancing molecular diagnostics and developing
📌 Senior Manager – R&D (Vapi)
🏢 Meril
📍 Vapi