Head of Manufacturing

5 days ago

Mumbai, Maharashtra, India MEDISPEC Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Role summary

Build and lead a new manufacturing line that formulates, fills, and packs PCR-based kits for food-safety testing (mycotoxin, allergen, GMO, pathogen panels). You will take the operation from bare floor to validated, audit-ready production and then drive continuous improvement.

Key responsibilities

  • Design and commission an ISO-class clean room for PCR kit assembly plus supporting powder-mix and warehouse areas.
  • Transfer and localise manufacturing SOPs; execute equipment qualification (IQ/OQ/PQ) and pilot-lot validation.
  • Establish and maintain ISO 9001 and FSSC 22000 quality systems; prepare dossiers for FSSAI Rapid Analytical Food-Testing (RAFT) approvals.
  • Create batch-record, supplier-qualification and change-control systems; build and train a production & QC team.
  • Represent the plant during external audits (certification bodies, FSSAI, customers) and drive yield, cost and lead-time improvements.

Background we're looking for

  • 8 + years
     in PCR, molecular-diagnostics or reagent manufacturing; direct experience with food, feed or environmental kits strongly preferred.
  • Demonstrated success commissioning ISO-7/8 clean rooms and validating utilities/equipment.
  • Hands-on implementation of 
    ISO 9001
     and/or 
    FSSC 22000
    ; familiarity with ISO/IEC 17025 or RAFT submissions is a plus.
  • Solid understanding of PCR assay components (enzymes, primers/probes, lyophilisation) and QC metrics such as Ct reproducibility, LOD and stability.
  • Proven project-management, vendor-negotiation and team-lead skills in a build-from-scratch environment.
  • Degree in Biotechnology, Microbiology, Biochemistry or related life science; postgraduate preferred.
  • Clear, confident communication in English; ability to work with international technical teams.

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