Senior Manager (Pilot Plant)

Position Summary

Lead manufacturing excellence by driving plant capacity utilization, process optimization, technology transfer, and implementation of innovative manufacturing technologies while ensuring the highest standards of GMP compliance and operational efficiency.

Responsibilities will include:

• Lab Demonstration, Kilo Lab & Pilot Batch Planning & Execution Before Scale-up (Commercialization) for new molecule.
• Evaluation of critical process parameter, study of in process checks, suggestion for minor modification for process feasibility at plant. To ensure the Development batches of new product in lab scale as per feasible to prepare in Pilot & plant/Commercial scale.
• Review Technical Documentation & Plant Capacity Utilization. To maintain quality standards in Pilot Plant batch with GMP norms.
• Preparing list of facility/modifications/installation/CAPEX requirement like equipments, utilities at Pilot Plant.
• New technology to be introduced on commercial scale to reduce RMC and Overhead cost of product.
• Preparation of Scaleup report, PFD, P & ID, RM norms, process time cycle, process volume, HAZOP/HIRA Study, Risk Assessment of Products.
• Debottlenecking and Capacity enhancement of existing molecules: Process
• intensification/ utility optimization/ new equipment selection/ projection of time cycle reduction.
• Batch planning and execution and products deliverables as per customer requirements.
• Technology Transfer of New molecules with desired timelines, yield, Quality, Safety (Zero Accident Goal) in Pilot Plant and Commercial Batch.
• To ensure the maintenance of the quality standards for all new developing and material generation products at Pilot Plant/Production by selecting Adequate equipment according to Process requirements.
• Coordination with R&D, QC, QA, EHS, Engineering etc. for smooth functioning of Technology Transfer and Production activities.
• Responsible for suggest necessary changes in Equipment Break down log book and reviewing Quarterly basis summary of planned vs actual maintenance equipment reports.
• To ensure the maintaining of the quality standards for all new products at Pilot Plant by selecting adequate equipment according to Process requirements.
• Review, Approve & check the inventory of critical Equipments & spares list.
• Prepared yearly production planning and executed monthly basis.
• Create a Production Order in SAP.
• Responsible to achieve monthly as well as yearly manufacturing target.
• Monitoring the production processes and adjusting the schedule as needed
• Ensure the production department is following all necessary EHS precautions while performing tasks.
• Investigate & implement adequate corrective & preventive actions against customer complaints.
• Responsible for creating work environment of “teamwork” in the production department.
• Responsible for identifying training needs and ensuring proper training is provided.
• Comply with applicable environmental, health, and safety laws and regulations, company policy, and accepted safe work practices.

Required Experience & Knowledge

Functional / Technical

1. Batch Planning and Execution

2.Handling of all equipment, utility, and manpower.

3.Tech Transfer & Scaleup Activities knowledge.

4. SOP & EHS Awareness.

5. Chemistry & Engineering Knowledge

6. Validation and Calibration of equipment

7. Trouble Shooting

8. SAP Activity& Documentation

9. Presentation & Communication skills

10. GMP Compliances
Behavioral

1. Strategic Leadership skills

2. Ethical Practice

3. People Management

4. Punctuality

5. Discipline

6. Enthusiasm

7. Cooperation

8. Positive attitude

9. Innovativeness

10. Result Orientation

11. Learning Agility

12. Effective communication and counselling skill

Supervisory Responsibilities

Yes