1. Role Purpose

To lead and manage External Manufacturing (EM) operations by ensuring successful technology transfer, process scale-up, manufacturing readiness, commercial production execution, process optimization, and cost-effective operations at toll manufacturing locations. The role acts as the key interface between R&D;, Technology & Development (T&D;), Supply Chain, Quality, EHS, and EM partners to ensure seamless product commercialization and reliable supply while maintaining safety, quality, delivery, and cost objectives.

2. Key Responsibilities

1. External Manufacturing Strategy & Planning

- Develop and execute External Manufacturing (EM) plans in consultation with business and functional stakeholders.
- Identify manufacturing capacities and capabilities available at toll manufacturing partners.
- Support sourcing and evaluation of potential External Manufacturing partners.
- Drive commercialization and scale-up projects through a structured execution framework.
- Monitor production plans and align output with business demand forecasts.
- Ensure optimum utilization of approved EM capacities.

2. Process Engineering & Technology Transfer

Engineering Documentation

- Prepare, review, and approve:
- Block Flow Diagrams (BFD)
- Process Flow Diagrams (PFD)
- Piping & Instrumentation Diagrams (P&ID;)
- Process Datasheets
- Utility Requirement Specifications
- Equipment Lists
- Ensure process engineering documentation complies with company standards.
- Review process modifications and maintain engineering document control.

Technology Transfer

- Witness demonstration batches at R&D; and Pilot Plant facilities.
- Understand reaction chemistry, critical process parameters, process hazards, and operating windows.
- Lead technology transfer from laboratory/pilot scale to commercial manufacturing.
- Independently implement and commercialize products at EM sites.
- Ensure successful execution of first-time commercial batches.

3. Material & Energy Balance Management

- Prepare detailed material balance and energy balance calculations.
- Establish raw material consumption norms for products.
- Determine utility requirements including (If required. As per current practice for existing product, Operation/T&D; has to provide):
- Steam
- Chilling Water
- Cooling Water
- Electricity
- Nitrogen
- Compressed Air
- Monitor actual consumption against design assumptions.
- Analyze deviations and implement improvement actions.
- Establish mass balance monitoring systems across manufacturing campaigns.

4. External Manufacturing Facility Assessment

- Conduct technical assessments of External Manufacturing facilities.
- Evaluate facility capabilities including:
- Reactor Sizing
- Distillation Systems
- Utility Infrastructure
- Storage Facilities
- Material Handling Systems
- Process Control Systems
- Verify suitability of equipment for intended processes.
- Assess manufacturing readiness before commercialization.




- Conduct periodic technical audits of EM facilities.

5. Site Readiness & Commissioning

- Coordinate with EM partners for readiness of equipment, manpower, utilities, and raw materials.
- Conduct pre-commissioning inspections and readiness reviews.
- Verify completion of engineering, safety, and operational requirements.
- Lead commissioning and start-up of commercial campaigns.
- Ensure smooth scale-up from pilot batch to commercial production.
- Support EM production teams during initial manufacturing campaigns.

6. Production Campaign Management

- Manage end-to-end manufacturing campaigns at toll manufacturing locations.
- Prepare batch execution plans and campaign schedules.
- Monitor:
- Production Progress
- Campaign Timelines
- Batch Performance
- Yield Achievement
- Resource Utilization
- Manufacturing Efficiency
- Track batch-wise production data and identify deviations.
- Publish weekly manufacturing reports and campaign performance updates.
- Prepare campaign closure reports and lessons learned documentation.

7. Process Optimization & Troubleshooting

- Provide technical troubleshooting support for ongoing manufacturing operations.
- Coordinate with R&D; and T&D; teams to resolve process challenges.
- Perform root cause analysis for:
- Yield Losses
- Process Deviations
- Quality Issues
- Production Interruptions
- Identify opportunities for:
- Yield Improvement
- Utility Reduction
- Throughput Enhancement
- Cycle Time Reduction
- Lead process optimization projects and continuous improvement initiatives.

8. Yield, Cost & Performance Management

- Monitor manufacturing economics and process efficiencies.
- Analyze:
- Product Yield
- Raw Material Consumption
- Solvent Recovery
- Utility Consumption
- Conversion Cost
- Establish and monitor manufacturing performance benchmarks.
- Develop cost-saving proposals and value-improvement initiatives.
- Evaluate tolling cost structures and support commercial negotiations.

9. SOP, Batch Card & Manufacturing Documentation

- Prepare and Support to EM Partner:
- Standard Operating Procedures (SOPs)
- Batch Cards
- Work Instructions
- Process Manuals
- Cleaning Procedures
- Manufacturing Standards
- Ensure implementation and compliance at EM sites.
- Develop monitoring mechanisms for SOP compliance.
- Ensure proper documentation of production activities.
- Drive standardization across multiple manufacturing locations.

10. Inventory, Logistics & Reconciliation Management

- Closely track movement of:
- Raw Materials (RM)
- Packing Materials
- Semi-Finished Goods (SFG)




- Finished Goods (FG)
- Coordinate logistics between company sites and EM locations.
- Monitor inventory levels and prevent material shortages.
- Conduct periodic reconciliation of:
- Raw Materials
- Solvents
- Intermediates
- Finished Products
- Analyze inventory variances and take corrective actions.
- Coordinate with Supply Chain and Stores teams for inventory optimization.

11. EHS & Regulatory Compliance

- Conduct EHS assessments of EM manufacturing facilities.
- Ensure implementation of recommendations arising from:
- Safety Audits
- Process Safety Reviews
- Job Safety Analysis
- EHS Inspections
- Verify compliance with:
- Environmental Regulations
- Monitor closure of EHS observations and recommendations.
- Promote a strong safety culture at EM sites.

12. Stakeholder Management & Cross-Functional Coordination

Internal Coordination

Coordinate extensively with:

- Research & Development (R&D;)
- Pilot Plant
- Technology & Development (T&D;)
- Production
- Quality Assurance
- Quality Control
- Supply Chain Management
- Procurement
- Logistics
- EHS
- Commercial & Finance Teams

External Coordination

Coordinate with:

- EM Partner
- SCM
- Company Logistic dept.

13. Reporting & MIS

- Prepare and present:
- Weekly Progress Reports
- Campaign Reports
- Yield Analysis Reports
- Variance Reports
- Cost Optimization Reports
- Commercialization Status Reports
- Review weekly production progress against plans.
- Report operational risks and delays to management.
- Develop dashboards and performance metrics for EM operations.

Technical Competencies

- External Manufacturing Management
- Technology Transfer & Commercialization
- Process Scale-up
- BFD, PFD & P&ID; Preparation
- Material & Energy Balance Calculations
- Yield Optimization & Cost Management
- Campaign Planning & Execution
- Continuous Chemical Process Operations
- Process Troubleshooting
- Root Cause Analysis (RCA)
- EHS & Process Safety Management
- Inventory & Reconciliation Management

Leadership Competencies

- Project Management
- Vendor Management
- Team Leadership
- Planning & Organizing
- Decision Making

Behavioral Competencies

- Solid Analytical Ability
- Result Orientation
- Problem Solving Mindset
- Proactive Approach
- Ownership & Accountability
- Collaboration & Teamwork
- Effective Communication Skills

14.Qualifications & Experience

Qualification

- BE / B. Tech – Chemical

Experience

- 12-18 years of experience in Chemical, Specialty Chemical, Agrochemical, Pharmaceutical, or MAH (Major Accident Hazard) Industries.
- Minimum 2-3 years of experience in External Manufacturing (EM) / Toll Manufacturing Operations preferred.
- Hands-on exposure to process scale-up, technology transfer, continuous improvement, and commercialization of chemical processes.

Experience handling critical high-pressure and high-temperature reactions.

📌 Associate Director – External Manufacturing (Chennai)
🏢 Navin Fluorine International
📍 Chennai