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: ₹40,000.00 - ₹80,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person