Senior Director, MS&T - Antibody Technical Product Steward

BioNTech•Gaithersburg, MD

30d•Onsite

About The Position

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

Responsibilities

Reporting to the Executive Director of Global MSAT
Manage technology and CMC alliances to advance BNT late-stage products and innovative technologies
Ensuring products are fit for late-stage technical feasibility, commercialization and meet CMC regulatory requirements
Sponsoring initiatives to incorporate lean practices
Mentoring junior functional leads
Advance product development
Ensure global goals and objectives are delivered
Advance the development and globalization of the company and drive the culture
Lead, manage and develop a department of employees responsible for MS&T activities
Establish BioNTech Global Technical Operations Product Champion team by collaborating with Development and Supply to optimize CMC handovers and procedures
Coach, mentor, collaborate, partner, at all levels with high visibility and engagement
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
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
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