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 (Rajkot)
🏢 Navin Fluorine International
📍 Rajkot