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

Bachelor’s Degree in Engineering, Life Sciences or related discipline
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.

Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance

Senior Director, MS&T – Antibody Technical Product Steward

Key skills