Business Capability Specialist

BioNTech • Berkeley Heights, NJ

4d

About The Position

As a Business Capability Specialist, you will serve as the critical link between our business stakeholders and the Data, Digital & Informatics (DDI) organization, ensuring that technology solutions seamlessly enable key business capabilities and support BioNTech’s mission. Working closely with Medical Affairs (MA) and Medical Safety & Pharmacovigilance (MSPv) teams, you will help identify opportunities for digital transformation, translate business needs into scalable technology solutions, and ensure compliance with regulatory standards. By combining your technical expertise with a strong understanding of business processes, you will play an integral role in driving innovation, improving operational efficiency, and delivering measurable value across the organization.

Requirements

• Bachelor’s degree in Computer Science, Mathematics, Information Systems, or Life Sciences-related fields
• 5+ years of experience as a Business Analyst within the Life Sciences industry; experience supporting Medical Affairs or MSPv is highly preferred
• Deep understanding of R&D business processes and data management within pharmaceutical settings
• Strong knowledge of technologies and trends in the pharmaceutical industry; experience supporting digital platforms commonly used in Global Development organizations is a plus
• Expertise in business process mapping efforts (as-is/to-be), gap analysis methodologies, project management principles, and leading international project teams
• Familiarity with GxP guidelines (e.g., 21 CFR Part 11) and Computer System Validation processes
• Exceptional analytical skills combined with a proactive mindset to solve complex problems collaboratively
• Superb interpersonal skills with an ability to engage effectively across diverse teams

Responsibilities

• Act as a trusted partner to Medical Affairs and MSPv teams to understand their needs and identify technology solutions aligned with BioNTech’s strategic goals
• Analyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency and effectiveness
• Lead or support the planning, prioritization, implementation, and operational management of technology projects within GxP environments
• Collaborate with cross-functional teams to develop process documentation (as-is/to-be), system requirements, functional specifications, and testing protocols
• Support technology roadmap development by working closely with Business Partners and portfolio management teams
• Partner with vendors to implement new technology solutions while ensuring seamless integration into existing systems
• Troubleshoot operational issues and ensure systems meet regulatory and validation requirements (e.g., 21 CFR Part 11, EMA Annex 11)
• Support GxP Computer System Validation activities by creating key documentation such as Validation Plans, User Requirements Specifications (URS), Testing Protocols (IQ/OQ/PQ/UAT), Traceability Matrices, and Validation Summary Reports
• Collaborate with procurement, legal, finance, quality partners, and other stakeholders on contracts and operational processes for quality systems

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level