Senior Subject Matter Expert (Biotechnology, Remote)

Job summary

This role involves acting as a global expert for starting materials in vaccine production, ensuring compliance and strategic oversight throughout the lifecycle of these materials. The position requires collaboration with various stakeholders to maintain supply reliability and regulatory adherence.

Qualifications

• Advanced degree (MSc or PhD) in biotechnology, virology, molecular biology, pharmaceutical sciences, or a related field
• Significant experience with late-phase or commercial biologics/vaccine products
• In-depth knowledge of cell banks, virus seeds, and lifecycle management in a GMP environment
• Strong understanding of global regulatory expectations (e.g., ICH Q5D, EMA/FDA)
• Experience with regulatory submissions and inspections
• Ability to interpret regulations with scientific confidence
• Excellent stakeholder management and communication skills
• Proficiency in English, both written and spoken

Responsibilities

• Define and manage the global strategy for starting materials, including cell banks and virus seeds
• Establish and uphold global procedures and standards for lifecycle management
• Monitor starting material status and identify critical future needs
• Collaborate on forecasting and capacity planning for materials
• Evaluate opportunities for shelf-life extension and replenishment strategies
• Provide expert input for development activities involving new cell lines
• Act as a regulatory partner, defining compliance requirements
• Support regulatory filings and health authority interactions
• Clarify roles and responsibilities across functions regarding starting materials
• Document knowledge to ensure transparency and continuity
• Offer scientific support for deviations and change controls

Skills

• Strong analytical and problem-solving skills
• Ability to work independently while influencing stakeholders
• Structured and reflective approach to complex topics

Education

• Advanced degree in a relevant scientific field

Tools

• Familiarity with regulatory frameworks and lifecycle management tools