Starting Material Subject Matter Expert (On-site)

Job summary

This role involves serving as the global expert for vaccine starting materials, including master and working cell banks, virus seeds, and lifecycle management. The position requires strategic oversight to ensure compliance and reliability in vaccine production.

Qualifications

• Advanced degree (MSc or PhD) in biotechnology, virology, molecular biology, pharmaceutical sciences, or a related field
• Solid experience with late-phase or commercial biologics/vaccine products
• Deep knowledge of cell banks, virus seeds, and starting material lifecycle management in a GMP environment
• Strong understanding of global regulatory expectations (e.g. ICH Q5D, EMA/FDA) and lifecycle activities such as variations, stability, and comparability
• Experience contributing to or leading regulatory submissions, responses, or inspections
• Ability to challenge and interpret regulations with scientific confidence and sound risk-based judgement
• Strong stakeholder management and communication skills, enabling alignment across sites and global functions
• Fluency in written and spoken English

Responsibilities

• Define and own the global strategy for starting materials, including cell banks and virus seeds
• Establish and maintain global procedures, standards, and technical requirements for starting material lifecycle management
• Maintain a holistic overview of starting material status, identifying critical needs
• Drive forecasting and capacity planning for starting materials in collaboration with manufacturing and supply chain
• Assess and enable shelf-life extension opportunities and replenishment strategies
• Provide expert input to development activities, including new or more stable cell lines
• Act as a regulatory sparring partner, challenging requirements and defining compliance standards
• Support and represent starting material topics in regulatory filings and inspections
• Ensure clear roles and responsibilities across functions related to starting materials
• Systematize and document knowledge for transparency and continuity
• Provide expert scientific support to deviations, investigations, and change controls

Skills

• Strong scientific judgement combined with pragmatic regulatory thinking
• Ability to work independently while influencing stakeholders
• Structured and reflective approach to complex topics

Education

• Advanced degree (MSc or PhD) in a relevant scientific field

Tools

• Familiarity with GMP environments and regulatory frameworks