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Johnson & Johnson

Makes prescription drugs and medical devices

Lead R&D - Transcend GTO Make

Program ManagementPosted on Nov 12
Full-time$112k - $180.6k

About the Job

Requirements

  • A minimum of a bachelor's degree in Business, Supply Chain, Engineering, Life Sciences, Information Systems, or a related discipline is required.
  • 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.
  • Proficiency in English, written and verbal, is required.

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 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 Advanced Therapies and Packaging Technology 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 Advanced Therapies and Packaging Technology operations.
  • Support solution confirmation, testing, deployment, readiness, adoption, stabilization, and continuous improvement for Advanced Therapies and Packaging Technology capabilities.
  • Support deployment of new capabilities while protecting compliance, product traceability, patient supply continuity, and operational readiness.

Desired Qualifications

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

About the Company

Johnson & Johnson

Makes prescription drugs and medical devices

Johnson & Johnson develops prescription medicines and makes medical devices for hospitals, and unlike most big drugmakers, it runs both businesses under one roof. In 2015, its Darzalex became the first antibody drug approved for multiple myeloma, a blood cancer. Its medicines treat cancer, immune diseases such as psoriasis, and mental illnesses such as depression, and patented drugs bring in most of its sales. Its MedTech unit makes heart pumps, catheters that treat irregular heartbeats, surgical sutures, and Acuvue contact lenses. It was founded in 1886 to make sterile surgical dressings, is based in New Brunswick, New Jersey, and spun off its consumer brands, such as Tylenol and Band-Aid, as Kenvue in 2023.

Company size
10,001+
Company stage
IPO
Headquarters
New Brunswick, NJ
Founded
1886

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