Business Capability Specialist

Cambridge, US;
Gaithersburg, US;
New Jersey, US | full time | Job

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.

• 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

• 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

Expected Pay Range: $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

• 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
• Sitter stream:
  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

…and more! More details to be shared.

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