Head MS&T DS CoE

IN04 (FCRS = IN004) Sandoz Private Limited; Telangana; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Sandoz Private Limited in India seeks a transformative leader to establish and head a world-class Drug Substance Process Science CoE, guiding scientific excellence across upstream and downstream biologics manufacturing for commercial and pipeline programs.

You will drive technical roadmaps, governance, and advanced analytics, mentoring senior teams, and partnering with manufacturing sites and regulatory bodies to ensure robust processes and continual improvement.

Qualifications

• Minimum MSc in Biotechnology, Biochemical Engineering, Pharmaceutical Sciences, Chemical Engineering, Biology, or related scientific discipline.
• Preferred PhD in relevant scientific discipline.
• Fluent English (written and spoken).

Responsibilities

• Lead Process Science CoE for biologics manufacturing platforms and establish global governance.
• Provide end-to-end technical oversight of upstream and downstream processes.
• Drive process robustness, yield improvement, and cost optimization initiatives.

Skills

Leadership

Strategic Leadership

Scientific Excellence

Business Acumen

Stakeholder Management

Organizational Development

Change Leadership

Talent Development

Decision Making

Innovation Mindset

Continuous Improvement

Education

MSc in Biotechnology/related

PhD (preferred)

Job description

Job Description Summary

Lead the Drug Substance Process Science Manufacturing Science & Technology Center of Excellence (CoE) responsible for scientific and technical leadership across upstream and downstream biologics manufacturing processes supporting commercial products, pipeline products, internal manufacturing sites, and external partners.

Job Description 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

• 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
• 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

Skills Desired

• Change Management
• Manufacturing Process Science
• Manufacturing Production
• Manufacturing Technologies
• Process Control
• Process Simulation
• Quality Compliance
• Technical Leadership
• Waterfall Project Management

Our Purpose

Here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!