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 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
Skills Desired
Change Management, Manufacturing Process Science, Manufacturing Production, Manufacturing Technologies, Process Control, Process Simulation, Quality Compliance, Technical Leadership, Waterfall Project Management
