Senior Vice President - API Manufacturing Operations

Location : Ankleswhar

Industry: Pharmaceutical

Designation: Sr. Vice president - API manufacturing operations

Role Purpose

The Head - API Manufacturing Operations will be responsible for providing strategic and operational leadership for all Active Pharmaceutical Ingredient (API) manufacturing activities across the site. The role will drive operational excellence, regulatory compliance, productivity enhancement, cost optimization, capacity expansion, and people development while ensuring uninterrupted supply of high-quality APIs for domestic and global markets.

The incumbent will work closely with Quality, Engineering, Supply Chain, EHS, R&D, Regulatory Affairs, and Commercial teams to achieve business objectives and support the organization's growth strategy.

Key Responsibilities

1. Manufacturing Leadership & Plant Operations

- Provide end-to-end leadership for API manufacturing operations including reaction, isolation, drying, milling, blending, and packaging activities.

- Ensure adherence to production plans while meeting quality, safety, delivery, and cost targets.

- Drive manufacturing excellence across multiple production blocks and facilities.

- Ensure optimum utilization of manpower, equipment, utilities, and manufacturing assets.

- Lead capacity planning and debottlenecking initiatives to support business growth.

2. Regulatory Compliance & Quality Excellence

- Ensure strict compliance with cGMP, ICH, USFDA, MHRA, EDQM, WHO-GMP, PMDA, ANVISA, and other applicable global regulatory requirements.

- Support regulatory inspections, customer audits, and corporate quality audits.

- Drive a culture of quality, data integrity, and compliance throughout the manufacturing organization.

- Ensure timely closure of deviations, investigations, CAPAs, change controls, and audit observations.

3. Operational Excellence & Productivity Improvement

- Champion Lean Manufacturing, Six Sigma, TPM, and Operational Excellence initiatives.

- Drive improvements in productivity, yield enhancement, cycle time reduction, and manufacturing efficiency.

- Establish and monitor KPIs related to OEE, throughput, batch cycle time, yield, and manufacturing cost.

- Lead digitalization and Industry 4.0 initiatives to improve plant performance and operational visibility.

4. Cost Management & Profitability

- Own manufacturing budgets and drive cost optimization initiatives.

- Improve material consumption efficiencies and reduce process losses.

- Monitor manufacturing costs, energy utilization, solvent recovery, and waste management programs.

- Collaborate with Procurement and Supply Chain teams to improve overall cost competitiveness.

5. New Product Commercialization & Technology Transfer

- Partner with R&D and Technology Transfer teams for smooth scale-up and commercialization of new APIs.

- Ensure seamless transfer of processes from laboratory to pilot and commercial scale.

- Support validation activities, process optimization, and commercial launch readiness.

- Accelerate time-to-market for strategic products.

6. Safety, Health & Environment (EHS)

- Foster a strong safety culture across manufacturing operations.

- Ensure compliance with statutory EHS regulations and company standards.

- Drive process safety management (PSM) initiatives and risk mitigation programs.

- Lead incident investigations and implementation of preventive measures.

7. Supply Chain & Business Alignment

- Collaborate with Supply Chain, Planning, and Commercial teams to ensure uninterrupted product availability.

- Participate in S&OP reviews and capacity planning discussions.

- Ensure achievement of customer service levels and inventory optimization targets.

- Support strategic business planning and growth initiatives.

8. People Leadership & Capability Building

- Lead and develop a large manufacturing workforce including production managers, shift leaders, engineers, and operators.

- Build succession pipelines and strengthen leadership capabilities across operations.

- Foster a culture of accountability, continuous improvement, and employee engagement.

- Drive performance management and talent development initiatives.

Educational Qualifications:

- B.E./B.Tech in Chemical Engineering, Chemical Technology, or equivalent.

- M.Tech, MBA (Operations), or advanced management qualification preferred.

Experience:

- 18-25 years of progressive experience in API manufacturing operations within leading pharmaceutical organizations.

Minimum 10+ years of leadership experience managing large-scale API manufacturing facilities.

- Proven experience handling USFDA, MHRA, EDQM, and other international regulatory inspections.

- Strong exposure to multi-product API manufacturing involving complex chemistries and large-scale operations.

- Experience in greenfield/brownfield expansion projects, capacity enhancement, and operational transformation initiatives is highly desirable.