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# Business Capability Specialist

- **Company:** Biontech Ag
- **Location:** Cambridge, MA, United States
- **Experience:** Expert
- **Salary:** $113,600.0 - $181,600.0
- **Contract:** Permanent contract
- **Skills:** Information Systems, Software Requirements Analysis, System Testing, Web Platforms, Iq/oq/pq, Information Technology, Data Management, GXP
- **Published:** May 19, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=c4a11037f9894d9f

## About the Role

* 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

## Description

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.

Your Contribution

 * 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


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