BioNTech SE · 15 hours ago
Senior Director, MS&T - Antibody Technical Product Steward
Gaithersburg, MD
Full-time
Onsite
Director/Executive
$199K/yr - $318K/yr
15+ years expBioNTech SE is a leading company in the biopharmaceutical industry, and they are seeking a Senior Director for their MS&T team. This role involves overseeing technology and CMC alliances for late-stage products, managing a team, and ensuring compliance with regulatory requirements.
Health Care
Responsibilities
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
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
Qualification
Required
Bachelor's Degree in Engineering, Life Sciences or related discipline required
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
Benefits
Benefits
Annual bonus
Equity
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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