Manufacturing Lead

Position - Manufacturing lead

Location - Turbhe, Navi Mumbai

Education Qualification - MSc, B. Tech, M. Tech, B. Eng

Company Website - https://haystackanalytics.in/

Who are we : 

HaystackAnalytics 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 do : 

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  Regulatory Compliance

  
  




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  Ensure manufacturing operations comply with CDSCO licensing requirements for IVD devices.

  
  


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  Ensure manufacturing operations meet regulatory requirements

  
  


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  Implement and maintain ISO 13485 and ISO 14971 standards for quality management and risk management.

  
  


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  Maintain audit-ready documentation for inspections and submissions.

  
  




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  Manufacturing Operations

  
  




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  Lead daily production activities, ensuring efficiency, safety, production timelines and adherence to SOPs.

  
  


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  Oversee documentation for batch-wise traceability.

  
  


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  Manage raw material procurement, in-process controls, and final product release.

  
  




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  Quality Assurance

  
  




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  Collaborate with QA to ensure validation of processes, equipment, and test methods.

  
  


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  Address CAPA and root cause analysis for deviations.

  
  




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  Team Leadership

  
  




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  Train and mentor production staff on GMP, QSR, and MDR requirements.

  
  


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  Coordinate cross-functional teams (R&D, QA, Regulatory Affairs) to align manufacturing with product development.

  
  




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  Risk & Safety Management

  
  




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  Implement risk management frameworks per ISO 14971.

  
  


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  Ensure workplace safety and adherence to biosafety protocols for handling biological samples.

  
  

Requirements : 

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  Bachelor’s/Master’s degree in Biotechnology, Biomedical Engineering, or related field.

  
  


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  5–10 years of experience in IVD manufacturing.

  
  


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  Strong knowledge of production requirements for IVDs.

  
  


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  Experience with ISO 13485-certified facilities and regulatory submissions.

  
  


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  Proven leadership in managing teams and scaling compliant manufacturing operations.

  
  

Skills : 

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  Strong documentation skills.

  
  


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  Ability to operationalize and improve workflows that align with regulatory requirements.

  
  


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  Collaborative leadership with focus on public health impact.