Transcend R&D GTO Make

The Lead R&D - AT - Transcend serves as the primary R&D business representative for Advanced Therapies (AT) and Packaging Technology (Pack & Tech). This senior individual contributor partners across business, site, process, deployment, and technology teams to translate business needs into process and solution requirements and to support design, build, testing, deployment, business readiness, adoption, stabilization, and continuous improvement.

Responsibilities

• Serve as the R&D process lead for Advanced Therapies and Packaging Technology across assigned Transcend releases and deployment activities.
• Represent R&D business requirements throughout process design, solution confirmation, build, testing, deployment, stabilization, and hypercare.
• Gather, analyze, document, validate, and prioritize business requirements, business scenarios, process flows, user stories, gaps, controls, and acceptance criteria.
• Facilitate workshops and working sessions with business process owners, global template owners, site representatives, subject matter experts, deployment teams, and J&J Technology.
• Drive alignment between R&D operational needs, site requirements, end-to-end business processes, and global template standards.
• Assess business impacts, compliance considerations, risks, issues, dependencies, and operational implications; develop mitigation plans and escalate unresolved decisions through governance.
• Lead or coordinate business impact assessments, readiness evaluations, stakeholder engagement, training inputs, communications, cutover preparation, go-live readiness, and stabilization activities.
• Develop, review, and confirm business scenarios and test cases; coordinate business participation in integrated testing and User Acceptance Testing; support defect triage and business acceptance.
• Maintain clear visibility of milestones, deliverables, actions, risks, issues, and dependencies for assigned process areas, aligned with program plans and governance expectations.
• Prepare concise status updates, recommendations, options, and decision requests for program and business leadership.
• Identify opportunities to simplify, harmonize, and improve processes while supporting compliance, patient supply continuity, operational readiness, and sustainable adoption.
• Represent Advanced Therapies requirements across clinical manufacturing and associated end-to-end clinical supply chain processes.
• Lead R&D business process activities for Packaging Technology, including packaging development, packaging specifications, labeling, packaging execution, and related data and system capabilities.
• Partner with site and global teams to incorporate AT and Pack & Tech requirements into future-state processes, data, integrations, controls, reporting, and system solutions.
• Collaborate across Clinical Supply Chain, Manufacturing, Quality, Logistics, Planning, Master Data, Finance, Packaging, and J&J Technology to ensure requirements are represented in end-to-end designs.
• Assess impacts to clinical manufacturing and packaging operations, specifications, labeling processes, interfaces, controls, reporting, user roles, product traceability, and operational readiness.
• Coordinate resolution of cross-functional process gaps, risks, and dependencies affecting AT and Pack & Tech operations.
• Support solution confirmation, testing, deployment, readiness, adoption, stabilization, and continuous improvement for AT and Pack & Tech capabilities.
• Support deployment of new capabilities while protecting compliance, product traceability, patient supply continuity, and operational readiness.

Qualifications

Education: A minimum of a bachelor's degree in Business, Supply Chain, Engineering, Life Sciences, Information Systems, or a related discipline is required.

Experience and skills: A minimum of 6 years of relevant experience in R&D, clinical supply chain, pharmaceutical or biotechnology operations, manufacturing, packaging, business process transformation, or enterprise deployment is required. Experience gathering and translating business requirements into process, data, system, or deployment deliverables is required. Experience working across global, cross-functional teams in a complex matrix environment is required. Demonstrated ability to independently lead workstreams, manage competing priorities, and influence stakeholders without direct authority is required. Strong analytical, process-mapping, problem-solving, facilitation, project execution, and decision-support capabilities are required. Excellent written and verbal communication skills, including the ability to communicate complex topics clearly to business and technical stakeholders, are required. Ability to identify and manage risks, issues, dependencies, and business impacts in a regulated environment is required.

Preferred: Experience with SAP S/4HANA or a comparable enterprise transformation program. Knowledge of Advanced Therapies, clinical manufacturing, Packaging Technology, packaging development, labeling, clinical supply chain, manufacturing operations, quality management, logistics, or master data. Experience supporting solution design, Fit-to-Standard activities, integrated testing, User Acceptance Testing, deployment, change impact assessment, business readiness, cutover, or hypercare. Experience with Agile delivery methods and tools such as Jira or comparable platforms. Experience working in a GxP-regulated environment and supporting validated business processes or systems.

Other: Proficiency in English, written and verbal, is required. This role requires approximately 10-15% domestic and international travel based on business and program needs. This position operates as a senior individual contributor and does not have direct people management responsibility. The role is expected to work collaboratively across global time zones and may require flexibility to support critical program activities.