Head of Manufacturing (PCR)

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.

• 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.

• 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.