- 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 Advantages Health insurance Provident Fund Work Location In person

📌 Head Of Manufacturing Operations (culture Media & Food Testing Kits) (Maharashtra)
🏢 Medispec (I
📍 Maharashtra