Vice President Operations
21 hours ago
Global Life Science Hub is searching for a Vice President of Operations in India with a deep Biologics Manufacturing background to provide executive leadership for a large-scale, fully integrated biologics manufacturing campus with up to 50,000L of drug substance and drug product capacity. This leader will own end-to-end site performance across manufacturing, engineering, facilities, automation, and capital expansion, supporting global clinical and commercial supply.
This role will be the senior-most operations leader in India, responsible for site build-out, start-up, scale-up, and long-term operational excellence, aligned with global supply strategy.
Responsibilities:
- Provide full executive leadership for India-based biologics manufacturing and engineering operations, covering upstream, downstream, formulation, and aseptic fill/finish.
- Own end-to-end site performance across safety, quality, delivery, cost, and people.
- Serve as primary site leader and strategic partner to global manufacturing, quality, technical operations, and supply chain leadership.
- Develop and execute the India site manufacturing strategy aligned with global clinical and commercial supply demands.
- Lead process scale-up, technology transfer, and commercial readiness for biologics products.
- Ensure robust capacity utilization and long-term expansion planning up to 50,000L.
- Own all engineering, facilities, utilities, validation, and automation functions.
- Lead major capital projects, including site expansions, new production lines, cleanroom build-outs, and infrastructure upgrades.
- Ensure facilities and systems are inspection-ready at all times for global regulatory agencies.
- Serve as executive site sponsor during regulatory inspections
- Drive a culture of compliance, data integrity, safety, and GMP excellence.
- Partner closely with Quality, Regulatory, and Global Technical Operations.
- Drive adoption of advanced manufacturing technologies, automation, MES, and digital plant initiatives.
- Champion continuous improvement, Lean Manufacturing, and Six Sigma across all functions.
- Build, mentor, and retain high-performing manufacturing, engineering, and facilities leadership teams.
- Own organizational design, succession planning, and leadership development for the India operations.
- Own site P&L performance, OPEX/CAPEX planning, and long-term capacity forecasting.
- Establish and manage critical vendor, equipment supplier, and CMO relationships in India and globally.
- Ensure materials readiness, production planning, and uninterrupted product supply.
Experience & Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or related discipline; advanced degree (MS, PhD, MBA) strongly preferred.
- 20+ years hands-on biopharmaceutical manufacturing
- Proven success in site start-up, expansion, and commercial readiness in biologics manufacturing.
- Deep hands-on expertise in upstream/downstream biologics operations and aseptic fill/finish.
- Demonstrated leadership of engineering and facilities functions, including capital project execution.
- Experience spanning clinical to large-scale commercial supply environments.
- Strong track record of regulatory inspection success and inspection-ready site leadership.
- Demonstrated impact in process optimization, cost reduction, and advanced technology implementation.
- Skilled in organizational design, change management, and leadership development.
- Knowledge of biologics supply chain management and partnerships with CMOs preferred.
- Exceptional communication, problem-solving, and decision-making skills, with a strategic, global mindset.
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