Specialist II, Supply Chain

About the role

Resilience is a technology-focused biomanufacturing company changing the way medicine is made by building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

Core Responsibilities

• Provide primary support and coordination for packaging documentation changes, including packaging artwork changes and Bill of Material (BOM) change form completion.
• Project manage packaging documentation changes from initial notification through implementation, ensuring sufficient time is available to implement the change to the timescales requested by the customer; understand market expectations and communicate throughout the site so that QA and Planning remain aligned.
• Create Operations Change Management (OCM) and Veeva records and appropriate Action Items to support the creation of new components and changes to existing components.
• Hold and participate in routine Job Tracking communication meetings with key assigned customers as needed, and maintain Job Tracking information for assigned jobs, including a forward view of upcoming changes.
• Maintain artwork within the appropriate artwork management systems and ensure approved documentation is transferred to approved vendors and suppliers as needed; manage the use of external artwork resources as appropriate; send artwork samples as required to the appropriate representative per MIF.

Systems & Master Data

• Set up and progress projects within Gazelle for Artwork Order Requests (AOR), Technical Labeling Request Forms (TLRF), and Labeling Request Forms (LRF) for packaging documentation changes.
• Initiate and maintain the SAP Master Data Governance (MDG) system for globally planned materials for the West Chester site.
• Coordinate SAP and D365 transactions required to create new components to ensure timely implementation.
• Serve as the site’s SAP super user and support the site with ERP master data queries; support the site with ERP (SAP/D365) access requests.

Collaboration & Continuous Improvement

• Support cross-site initiatives to standardize workflows and align processes with internal and external customers.
• Participate in inter-departmental and inter-company project teams, representing packaging, documentation and master data requirements.
• Interface with Marketing, Operations, Project Management, Quality Assurance, and Development personnel.
• Create and update supporting documentation for specific job functions; support various site-driven projects and market launches.

Minimum Qualifications

• Experience in one or more of the following areas: packaging operations, production planning, quality assurance, IQC packaging technical services, or MRP and advanced planning systems.
• Working knowledge of packaging processes, artwork processes, compliance issues, and cGMPs.
• Knowledge of cGMP and FDA regulations involving data management and validation requirements.
• Detailed knowledge of SAP, Material Resource Planning (MRP), and advanced planning systems related to pharmaceutical production processes.
• Strong interpersonal, project management, and coordination skills.
• Analytical, assertive, highly disciplined, and independent, with demonstrated high-level attention to detail and the ability to prioritize competing work with minimum supervision.

Preferred Qualifications

• Bachelor’s degree, preferably in a technical or scientific field, with knowledge of MRP and planning related to pharmaceutical production processes.
• 3+ years of experience in packaging documentation, artwork management, supply chain or a related function within a cGMP-regulated environment.
• Experience with change management (Veeva or TrackWise).
• Proven ability to work independently and professionally in a cGMP-regulated environment.
• Knowledge of inventory control and document management systems.

Physical & Work Environment

• Work is performed onsite at the West Chester supply site in a combined office and cGMP manufacturing environment.
• Requires periodic access to packaging and production areas, including gowning and adherence to area-specific requirements where applicable.
• Requires extended periods of computer-based work reviewing artwork, master data, and change documentation.
• Occasional business travel may be required to support cross-site initiatives and supplier coordination.

The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.

Sponsorship or support for work authorization, including visas, is not available for this position.

Pay

The target base pay hiring range for this position is $60,000.00 – $93,750.00 per year. Actual base pay is dependent upon the candidate’s geographical location, relevant experience, qualifications, skills, and knowledge.