Head of Manufacturing Operations

2 days ago

Mumbai, Maharashtra, India Medispec (I) Ltd Full time ₹ 38,40,000 - ₹ 96,00,000 per year

Job Description – Head of Manufacturing Operations (Culture Media & Food Testing Kits)Role Summary

Lead and scale a new manufacturing operation producing microbiological culture media (agar plates, broths, enrichment media) and PCR-based food safety testing kits (for mycotoxin, allergen, GMO, and pathogen detection). You will take the plant from bare floor to validated, audit-ready production and then drive continuous improvement across both product lines.

Key Responsibilities

Facility & Infrastructure

· Design and commission media preparation, sterilization, aseptic filling, and cleanroom areas (ISO-7/8 for PCR-based kits; controlled areas for culture media).

· Oversee installation and qualification of autoclaves, mixers, lyophilizers, filling/packaging lines, and QC instruments.

· Ensure robust utilities and cleanroom support systems (HVAC, water purification, compressed gases).

Operations & Quality

· Transfer and localize manufacturing SOPs for both culture media and food testing kits.

· Execute equipment qualification (IQ/OQ/PQ), method validation, and pilot-lot production.

· Establish and maintain ISO 9001, FSSC 22000, and GMP-compliant systems.

· Prepare regulatory dossiers for FSSAI Rapid Analytical Food-Testing (RAFT) approvals and support customer audits.

· Implement batch records, change control, supplier qualification, and traceability systems.

· Build and train a cross-functional team for Production, QC, and Maintenance.

Continuous Improvement

· Monitor KPIs: yield, cost, lead time, OEE, complaint rate.

· Drive lean-manufacturing initiatives and scale-up of production volumes.

· Represent the site during external audits and certifications.

Background We're Looking For

· 4+ years in microbiological culture media or reagent manufacturing for food safety applications. Experience with PCR-based food testing kits strongly preferred.

· Proven success commissioning media preparation lines and/or ISO-class cleanrooms.

· Hands-on experience with ISO 9001, FSSC 22000, GMP; familiarity with ISO/IEC 17025 or RAFT submissions is a plus.

· Strong understanding of culture media formulation (agar, broths, selective supplements) and PCR kit components (enzymes, primers/probes, lyophilization).

· Knowledge of QC metrics for both product families (growth-promotion testing, sterility checks, Ct reproducibility, LOD, stability studies).

· Demonstrated project management, vendor negotiation, and team leadership in a build-from-scratch environment.

· Degree in Biotechnology, Microbiology, Biochemistry, or related life sciences; postgraduate preferred.

· Clear, confident communication in English; ability to interface with international partners.

Job Type: Full-time

Pay: ₹40, ₹80,000.00 per month

Benefits:

  • Health insurance
  • Provident Fund

Work Location: In person

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