Senior Director, MS&T - Antibody Technical Product Steward

Primary responsibilities include:

Reporting to the Executive Director of Global MSAT, the Senior Director has both functional accountabilities and enterprise accountabilities. This role will work in close collaboration and partnership with enterprise stakeholders to manage technology and CMC alliances to advance BNT late-stage products and innovative technologies. Accountabilities include ensuring products are fit for late-stage technical feasibility, commercialization and meet CMC regulatory requirements, sponsoring initiatives to incorporate lean practices, and mentoring junior functional leads. This role will work in close collaboration and partnership with Global Technical Development and Global Supply Operations to advance product development, and with key stakeholders for product supply including Manufacturing, Quality, Supply Chain, and other regional and global functions.

The Senior Director of MSAT is a key leadership role for BioNTech Global MSAT team serving as a key enterprise leader to ensure global goals and objectives are delivered, advance the development and globalization of the company and drive the culture.  The candidate will be responsible to lead, manage and develop a department of employees responsible for MS&T activities.

This position requires working on-site as an essential function.

• Establish BioNTech Global Technical Operations Product Champion team by collaborating with Development and Supply to optimize CMC handovers and procedures
• Hands-On leader with high level of engagement within function and cross-functionally including with peers locally and globally.  Responsible to coach, mentor, collaborate, partner, at all levels with high visibility and engagement.
• Enterprise leader responsible for alignment and delivery of goals and objectives across function, site, regional and global level
• Partners in the development and execution of long-term manufacturing strategy in line with site and global initiatives to include new technology and process introduction into manufacturing operations
• Responsible for commercial products CMC lifecycle activities including post approval change management, product risk management, and process monitoring
• Active management of employees, reflecting on problems, solutions, and challenges, thereby creating a culture of continuous improvement and contributing towards becoming a learning organization
• Continuous improvement mindset finding ways to improve efficiency of an operation collecting, analyzing & evaluating data
• Contribute to MSAT team development and capability for products providing strategic leadership and direction aligned with the pipeline strategy with our global manufacturing vision and strategy
• In close collaboration and partnership with late-stage development support process and technology implementation, site process qualification/comparability campaign planning and execution, manufacturing process support including critical/major deviation investigations and product impact assessments, process monitoring and improvement, and site regulatory support with filings and inspections as needed
• Provide technical support to regulatory filings, regulatory inspections, and health authority questions as needed
• In collaboration with other functions globally, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for Deviation Investigations, Technology Transfer, Process Monitoring, Raw Material Qualification, and other relevant areas

Requirements:

• Bachelor's Degree in Engineering, Life Sciences or related discipline required, with 15 plus 15+ years of Biopharmaceutical industry experience in roles of increased leadership and responsibility in manufacturing, MSAT, process development in biologics
• Strong technical foundation (at least 5 years) for antibody development, product CMC lifecycle management and antibody manufacturing
• Experience leading direct reports and managing in a complex matrix environment at a local and global level
• Proficient knowledge of manufacturing processes, CMC requirements, process technologies and regulatory requirements
• Experience with lean manufacturing and lean six sigma
• Excellent communication, interpersonal and collaboration skills.
• Demonstrates strong interpersonal skills in dealing with all levels of management, having the ability to influence other team members of the organization
• Strong analytical, organizational, problem solving and project management
• Willingness to think outside of the box and adapt best practices in a constantly evolving environment
• Passion to build organizations, processes, systems, and people

US based candidates expected Pay Range: $198,900 to $318,300/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.