Major Accountabilities

Organizational Leadership

- Establish a world-class Process Science CoE supporting all biologics manufacturing platforms.
- Develop technical roadmaps for improvement in fed-batch, intensified and continuous manufacturing technologies.
- Drive harmonization of scientific standards, best practices and technical governance across all manufacturing sites.
- Establish the CoE as the central knowledge hub for drug substance manufacturing processes.

Scientific &

- Technical Leadership

- Provide end-to-end technical oversight of upstream and downstream manufacturing processes.
- Serve as global SME for commercial biologics process performance, process characterization and process robustness.
- Lead scientific assessment of process performance trends, process capability and manufacturing excellence initiatives.
- Provide governance for complex technical investigations, atypical events and major product-impact assessments.
- Drive deployment of advanced process control strategies and data-driven manufacturing approaches.

Manufacturing Support

- Ensure timely scientific support for routine commercial manufacturing.
- Act as escalation point for critical manufacturing issues, deviations, and product impact assessments.
- Lead complex technical investigations and root cause analyses.

Process Lifecycle Management

- Own lifecycle management of commercial manufacturing processes.
- Drive process robustness, yield improvement, productivity enhancement, and cost optimization initiatives.
- Ensure effective Continued Process Verification (CPV) and process monitoring programs.

Technology Transfer

- Support/Lead transfers of commercial and development products into and out of the site.
- Ensure effective transfer of process knowledge, control strategies, and manufacturing expertise.
- Establish risk-based transfer plans and governance structures.

Validation and Compliance





- Provide technical leadership for process characterization, PPQ, comparability and validation lifecycle activities.
- Support global regulatory submissions and agency interactions.
- Maintain inspection readiness across the manufacturing network.
- Provide scientific justification and technical defense during regulatory inspections.

Innovation &

- Emerging Technologies

- Evaluate emerging manufacturing technologies and industry trends.
- Drive adoption of advanced analytics, digital twins, AI-enabled manufacturing and predictive process monitoring.
- Build partnerships with equipment suppliers, technology providers and academic institutions.
- Sponsor innovation programs improving manufacturing flexibility, robustness and cost competitiveness.

People Leadership

- Lead and develop global Process Science leaders and subject matter experts.
- Build organizational capability in USP, DSP and continuous manufacturing.
- Establish succession planning and talent pipelines.
- Foster a culture of scientific excellence, collaboration, innovation and accountability.

Stakeholder Management

- Serve as technical representative to Global MS&T;, Regulatory Affairs, Quality, Supply Chain, and Manufacturing Operations.
- Lead technical governance forums and cross-functional decision-making processes.

Competencies

Leadership Competencies

- Strategic Leadership
- Scientific Excellence
- Business Acumen
- Stakeholder Management
- Organizational Development
- Change Leadership
- Talent Development
- Decision Making
- Innovation Mindset
- Continuous Improvement





Key Performance Indicators Supply &

- Manufacturing Excellence

- Supply reliability (% batches released / no supply interruptions)
- Right-First-Time (RFT) manufacturing rate
- Process yield achievement
- Process capability (CpK/PpK) for critical processes

Quality &

- Compliance

- Critical/major inspection observations
- Overdue deviations and CAPAs
- Recurring deviation rate
- Products maintained in validated state

Lifecycle &

- Technical Delivery

- Technology transfers delivered On-Time-In-Full (OTIF)
- Process validation / CPV milestones achieved
- Lifecycle change implementation success rate
- Technical project milestone adherence

Continuous Improvement

- Yield, throughput, or productivity improvements delivered
- Cost savings/value generation from process improvements
- Digital/PAT implementation milestones achieved

People &

- Organization

- Employee engagement score
- Talent retention and succession readiness
- Training compliance

Ideal Background

Education Minimum

- MSc in Biotechnology, Biochemical Engineering, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline

Preferred

- PhD in relevant scientific discipline

Languages

- Fluent English (written and spoken)

Experience Minimum

- 15+ years in Biologics Manufacturing, MS&T;, Process Development, or Technical Operations
- 7+ years leading technical organizations
- Experience supporting commercial biologics manufacturing
- Deep expertise in upstream and/or downstream processing
- Proven technology transfer leadership experience
- Experience supporting regulatory inspections

Preferred

- Continuous manufacturing experience
- Perfusion manufacturing experience
- Advanced process control and PAT experience
- Global network leadership experience
- Multi-site manufacturing support experience

📌 Head MS&T DS CoE (Telangana)
🏢 Sandoz India
📍 Telangana