Resilience (National Resilience, Inc.) is a first-of-its-kind manufacturing and technology company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale.

Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract manufacturing and development organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry’s adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.

As a Serialization Business Analyst on the Global Digital team you will bring to realization the Resilience digital strategy across the manufacturing network. You’ll work with manufacturing, supply chain, quality and other key stakeholders to define the requirements for the next generation of manufacturing systems implementation. This includes leading the specification, configuration, administration, and maintenance of the manufacturing systems platforms. You will be a key collaborator within the Digital team to ensure integrations of all required systems is achieved. You'll need a strong sense of curiosity and growth mindset with a willingness to share and brainstorm new ways to do things.

Responsibilities

• Lead the implementation and management of serialization systems in compliance with the Drug Supply Chain Security Act (DSCSA) and other global regulations (EU FMD, China).
• Configure serialization software and participate in onboarding initiatives with suppliers and customers.
• Collaborate with Digital and business stakeholders to define, design, and develop serialization solutions that meet business requirements.
• Monitor and analyze serialization data to ensure accuracy and compliance.
• Manage operational enhancements and integrations related to serialization.
• Provide support for long-term operations and create a support strategy and framework.
• Ensure no product supply interruptions by investigating and resolving issues in a timely manner with internal and external stakeholders.
• Develop, modify, and maintain system documentation (e.g specifications, procedures, work instructions, job aids).
• Coordinate with Digital Quality and Computer System Validation teams to generate and implement lifecycle documentation and validation protocols.

Minimum Qualifications

• Substantial experience in manufacturing, Supply Chain, or Information Technology.
• Progressive experience in life sciences manufacturing with a focus on serialization.
• Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment with a proven track record for delivering results on large, cross functional, global projects
• Hands-on experience with IT change management across domains (security, software, network, hardware, etc.) in a regulated (GMP) environment
• Fluid collaboration skills across business, IT, and external vendors/suppliers.

Preferred Experience

• 5+ years of experience in manufacturing, Supply Chain, or Information Technology.
• 2-3 years of experience in life sciences manufacturing with a focus on serialization.
• Bachelor’s degree in Business, Supply Chain, Information Technology, or related field.
• Demonstrated experience with serialization platforms, such as RFXcel, TraceLink, SAP ATTP, and Systech.
• Fluency in supporting the digitization of manufacturing & engineering business process by bringing the IT know-how to business partners in Manufacturing and Technical Operations.
• Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.