Manufacturing Lead

Position- Manufacturing leadLocation- Turbhe, Navi MumbaiEducation Qualification- MSc, B. Tech, M. Tech, B. Eng, B. PharmCompany Website- Are WeHaystackAnalytics is a HealthTech company creating clinical genomics products, which enable diagnostic labs and hospitals to offer accurate and personalized diagnostics. Supported by India's most respected science agencies (DST, BIRAC, DBT, etc.), we created and launched a portfolio of products to offer genomics in infectious diseases. Our genomics-based diagnostic solution for Tuberculosis was recognized as one of top innovations supported by BIRAC in the past 10 years, and was launched by the Prime Minister of India in the BIRAC Showcase event in Delhi, 2022.What We Want You To DoRegulatory Compliance○ Ensure manufacturing operations comply with CDSCO licensing requirements for IVD devices.○ Maintain adherence to FDA regulations for IVDs, including design controls, production, and process validation.○ Implement and maintain ISO 13485 and ISO 14971 standards for quality management and risk management.Manufacturing Operations ○ Lead daily production activities, ensuring efficiency, safety, and adherence to SOPs. ○ Oversee Device Master Records (DMF) and Device History Records (DHR) for batch-wise traceability. ○ Manage raw material procurement, in-process controls, and final product release. Quality Assurance ○ Collaborate with QA teams to ensure validation of processes, equipment, and test methods. ○ Drive CAPA (Corrective and Preventive Actions) and root cause analysis for deviations. ○ Ensure documentation is audit-ready for CDSCO inspections and FDA audits. Team Leadership○ Train and mentor production staff on GMP, QSR, and MDR requirements.○ Foster a culture of compliance, accountability, and continuous improvement.○ Coordinate cross-functional teams (R&D, QA, Regulatory Affairs) to align manufacturing with product development.Risk & Safety Management ○ Implement risk management frameworks per ISO 14971. ○ Ensure workplace safety and adherence to biosafety protocols for handling biological samples.RequirementsBachelor's/Master's degree in Biotechnology, Biomedical Engineering, or related field. 5–10 years of experience in medical device or IVD manufacturing. Strong knowledge of CDSCO MDR 2017 and FDA 21 CFR Part 820. Experience with ISO 13485-certified facilities and regulatory submissions. Proven leadership in managing teams and scaling compliant manufacturing operations.SkillsSystems thinking and process mapping for regulatory traceability. Strong documentation and SOP drafting skills. Ability to operationalize compliance into actionable workflows. Collaborative leadership with focus on public health impact.Skills: manufacturing,iso,management,cdsco

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