Production / Manufacturing Head

About the Role: We are a growing medical device company setting up a new manufacturing unit in YEIDA, Greater Noida. We are seeking a highly experienced and driven Product Head – Reagent Manufacturing (IVD) to lead our in-house reagent production, ensure regulatory compliance, and establish GMP-grade manufacturing practices. You will be responsible for scaling production, managing the team, ensuring documentation, and maintaining the highest quality standards. Key Responsibilities: Manufacturing & Process Management Lead end-to-end manufacturing of IVD reagents (electrolyte, hematology, or similar). Manage production processes involving filtration, chemical mixing, and batch processing. Define SOPs and ensure strict adherence to quality control and assurance standards. Regulatory & Documentation Maintain comprehensive ISO 13485-compliant documentation. Ensure all processes are aligned with MDR 2017 and other applicable regulatory frameworks. Prepare for and lead regulatory audits (CDSCO, ISO, client inspections). Oversee batch records, stability studies, traceability records, and COA generation. Team & Facility Management Hire, train, and manage manufacturing and quality staff. Oversee reagent production area, ensuring cleanliness, safety, and operational efficiency. Ensure calibration and readiness of all production and lab equipment. Infrastructure & Systems Define system protocols for inventory control, environment monitoring, and waste handling. Ensure proper documentation and tracking systems are in place for all operations. Key Requirements: Minimum 5–10 years of experience in IVD reagent manufacturing – preferably in Hematology, Biochemistry, or Electrolyte reagents. Strong understanding of chemical processes, filtration methods, and contamination control. Deep familiarity with ISO 13485, MDR 2017, and relevant IVD documentation practices. Proven experience in facing audits and handling regulatory compliance independently. Strong leadership, process discipline, and documentation skills. Qualifications: M.Sc. / B.Tech / M.Tech in Biotechnology, Biochemistry, Chemistry, or related fields. Additional certifications in Quality Systems, GMP, or Regulatory Affairs will be preferred. What We Offer:Leadership role in a rapidly growing IVD company. Opportunity to shape a modern reagent manufacturing facility from the ground up. Full ownership of product quality and process implementation. Growth-oriented work environment with long-term career prospects.