Senior Director, MS&T - Antibody Technical Product Steward

BioNTech•Gaithersburg, MD

34d

About The Position

As Senior Director of Global MSAT, you will play a pivotal leadership role in advancing BioNTech’s late-stage products and innovative technologies. Reporting to the Executive Director of Global MSAT, you will hold both functional and enterprise accountabilities, ensuring products are technically feasible for commercialization while meeting CMC regulatory requirements. You will lead and develop a team responsible for MSAT activities, collaborating closely with Global Technical Development and Global Supply Operations to drive product development and manufacturing strategies. This high-visibility role requires hands-on leadership, cross-functional collaboration, and a commitment to fostering a culture of continuous improvement across local, regional, and global levels. Your Contribution: Establish BioNTech’s Global Technical Operations Product Champion team to optimize CMC handovers and procedures Provide hands-on leadership by coaching, mentoring, collaborating, and partnering at all organizational levels locally and globally Align and deliver goals across functional, site, regional, and global levels as an enterprise leader Develop long-term manufacturing strategies aligned with site and global initiatives, including introducing new technologies/processes into manufacturing operations Lead commercial product CMC lifecycle activities such as post-approval change management, product risk management, and process monitoring Create a culture of continuous improvement by actively managing employees, solving challenges, analyzing data, and driving efficiency improvements Provide strategic direction for MSAT team development aligned with pipeline strategy and global manufacturing vision Collaborate with late-stage development teams to support process/technology implementation, site process qualification/comparability campaigns, deviation investigations/product assessments, process monitoring/improvement efforts Offer technical support for regulatory filings/inspections and address health authority questions when needed Implement fit-for-purpose systems/business processes globally to ensure compliance with corporate guidelines for deviation investigations, technology transfer, process monitoring, raw material qualification

Requirements

Bachelor’s Degree in Engineering, Life Sciences or related discipline with 15 plus years of biopharmaceutical industry experience in manufacturing/MSAT/process development roles; strong technical foundation in antibody development/manufacturing required
Experience leading direct reports and managing in a complex matrix environment at local/global levels
Proficient knowledge of manufacturing processes, CMC requirements/process technologies/regulatory requirements
Expertise in lean manufacturing/lean six sigma methodologies
Excellent communication skills with proven ability to collaborate/influence across all levels of management
Strong analytical/organizational/problem-solving/project management skills coupled with adaptability in evolving environments
Passion for building organizations/processes/systems/people while fostering innovation

Responsibilities

Establish BioNTech’s Global Technical Operations Product Champion team to optimize CMC handovers and procedures
Provide hands-on leadership by coaching, mentoring, collaborating, and partnering at all organizational levels locally and globally
Align and deliver goals across functional, site, regional, and global levels as an enterprise leader
Develop long-term manufacturing strategies aligned with site and global initiatives, including introducing new technologies/processes into manufacturing operations
Lead commercial product CMC lifecycle activities such as post-approval change management, product risk management, and process monitoring
Create a culture of continuous improvement by actively managing employees, solving challenges, analyzing data, and driving efficiency improvements
Provide strategic direction for MSAT team development aligned with pipeline strategy and global manufacturing vision
Collaborate with late-stage development teams to support process/technology implementation, site process qualification/comparability campaigns, deviation investigations/product assessments, process monitoring/improvement efforts
Offer technical support for regulatory filings/inspections and address health authority questions when needed
Implement fit-for-purpose systems/business processes globally to ensure compliance with corporate guidelines for deviation investigations, technology transfer, process monitoring, raw material qualification