Senior Scientist, Process Validation

Role Summary

The Senior Scientist serves as a key member of the global Life Cycle Management team, responsible for developing, implementing, and governing validation strategies across the Advanced Therapies network. This role focuses on global alignment, standardization of validation approaches, and strategic oversight of Tech Transfer, PPQ campaigns, CPV programs, and digital readiness. This role partners closely with regional MSAT, R&D, Quality, Regulatory, and Engineering teams to ensure consistent, compliant, and innovative validation practices globally.

Operational Excellence & Governance

• Define and maintain global Validation Master Plans and governance frameworks for ATMP processes.
• Drive global implementation of risk-based validation approaches aligned with ICH Q8/Q9/Q10, Annex 15, and FDA/EMA guidance.
• Author harmonized validation standards and templates across the global network.
• Provide strategic oversight for PPQ campaigns implemented at multiple sites, ensuring consistency and compliance.
• Support global CPV strategy, apply data analytics, statistical tools, and risk management principles to evaluate process capability and drive data-informed decisions.
• Support lifecycle improvement initiatives and evaluate digital tools for process monitoring.
• Partner with regional and site teams to assess validation readiness for new technologies and platforms.
• Support and author regulatory submissions with globally aligned validation documentation and strategies.

Cross-Functional Leadership & Communication

• Act as an inspiring leader, mentoring teams and influencing global validation policy and innovation.
• Facilitate collaboration and communicate program goals, progress, risks, and results to senior leadership and technical teams with clarity and influence.

Education:

• Bachelor's degree in biology, biotechnology, or related scientific field is required; advanced degree or equivalent experience preferred.

Skills & Experience:

• 7+ years proven experience within a regulated biologics or pharma industry
• Experience in global process validation strategy, governance, and regulatory compliance for ATMPs.
• Strong understanding of risk-based validation principles and Health Authority expectations.
• Demonstrate the ability to work effectively in cross-functional environment and influence global teams

Preferred Qualifications:

• Prior experience in cell culture or viral vector commercial manufacturing is highly desired.
• Knowledge in statical process control and analytical data modeling.
• Experience in digital solution implementation and deployment.
• Knowledge in data management platforms and data governance

Other Requirements:

• International travel to partner sites and global meetings, up to 20% of the time. Flexibility to work remotely when not travelling.
• Language requirements – fluency in English required; additional languages preferred.

Preferred Skills:

Agile Manufacturing, Business Process Design, Coaching, Communication, Critical Thinking, Good Manufacturing Practices (GMP), Innovation, Manufacturing Engineering, Manufacturing Flow Management, Manufacturing Processes, Plant Operations, Proactive Behavior, Problem Solving, Product Development Lifecycle, Production Operations, Profit and Loss Responsibility, Robotic Automation, Structural Fabrication, Sustainability

Hybrid Work