Assistant Manager (Molecular Diagnostics)
We are looking for a highly skilled Molecular Diagnostics Manufacturing Specialist to join our team as a Sr. Executive or Assistant Manager. This role is critical to our Molecular Diagnostics manufacturing operations at our IMT Manesar facility.
Role Overview
Designation: Sr. Executive / Assistant Manager (Molecular Diagnostics)
Experience: 6–7 Years
Education: B.Tech (Biotechnology), B.Sc., M.Sc., M.Tech (Biotechnology/Microbiology/Molecular Biology), or equivalent
Location: IMT Manesar, Gurugram
What You'll Do
As a key leader in the Molecular Diagnostics section, you will oversee manufacturing operations, process optimization, quality compliance, and technical activities related to molecular diagnostic products.
Key Responsibilities
- Manufacturing Operations: Manage reagent preparation, formulation, dispensing, filling, labeling, and packaging processes for molecular diagnostic kits.
- PCR Reagent Handling: Prepare and handle PCR Master Mixes, primers, probes, enzymes, buffers, and other molecular reagents while maintaining contamination-free operations.
- Production Equipment: Operate and supervise automated liquid handling systems, reagent filling machines, lyophilizers (if applicable), and other molecular production equipment.
- Process Control: Monitor manufacturing parameters, process validation, yield improvement, and production efficiency through statistical analysis and process monitoring.
- Quality Assurance: Ensure compliance with GMP, ISO 13485, cleanroom requirements, contamination control practices, and internal quality standards.
- Documentation: Prepare Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, validation protocols, deviation reports, CAPA documentation, and audit-ready records.
- Team Leadership: Lead production teams, coordinate cross-functional activities with QA, QC, R&D, and Warehouse departments, and drive continuous process improvements.
- Regulatory Compliance: Support internal, customer, CDSCO, ISO, WHO, and regulatory audits while ensuring complete documentation and traceability.
What We're Looking For
- 6–7 years of experience in Molecular Diagnostics, PCR reagent manufacturing, IVD, biotechnology, pharmaceuticals, or medical device manufacturing.
- Strong knowledge of PCR, RT-PCR, qPCR, nucleic acid extraction, contamination control, and molecular biology principles.
- Hands-on experience in cleanroom manufacturing and regulated production environments.
- Sound understanding of GMP, ISO 13485, documentation practices, and regulatory compliance.
- Strong analytical, problem-solving, leadership, and team management skills.
- Excellent communication skills with the ability to coordinate across multiple departments.
How to Apply
Interested candidates can reach out directly via:
Email: [email protected]
WhatsApp/Call: +91-9560727259
Job Type: Full-time
Pay: ₹404,055.36 - ₹1,825,355.94 per year
Benefits:
- Cell phone reimbursement
- Commuter assistance
- Food provided
- Health insurance
- Leave encashment
- Paid sick time
- Provident Fund
Work Location: In person
