Senior Director Process Engineering Peptides API

Job description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Position Summary: The Sr Director Process Engineering Peptides API sets enterprise direction and senior technical governance for process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery for biologics drug substance and cell and gene therapy manufacturing within AbbVie Strategic Investment. The role supports Strategic Investments through engineering leadership, technical expertise, standards development, technical governance and project execution support across multiple manufacturing sites, strategic investments and technology platforms. The role supports engineering activities associated with peptides manufacturing facility investments, new production capabilities, strategic capacity creation, advanced manufacturing platforms and new technology deployments across the Strategic Investment portfolio. The role partners with Strategic Investments, manufacturing sites, operations, quality, EHS, validation / CQV and external engineering partners to deliver technically robust and business-aligned engineering solutions. Strategic Investment Context Strategic Investment provides engineering leadership, technical governance, standards development and project execution support across AbbVie’s Strategic Investments and strategic capital portfolio. The organization supports new biologics drug substance and cell and gene therapy manufacturing facilities, new platform deployments, strategic capacity creation, advanced biologics and CGT manufacturing capabilities and standards development for emerging technologies across Strategic Investments. Strategic Investment roles are expected to promote common standards, transfer lessons learned across regions and sites, and enable consistent engineering delivery across strategic capital investments. Key Responsibilities: Strategic Investment Governance and Standards: Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics drug substance and cell and gene therapy process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery. Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects. Define enterprise standards, engineering requirements and technical guardrails for new biologics drug substance and cell and gene therapy technologies, including requirements for consistent design, deployment, qualification, operation and scale-up across Strategic Investments. Ensure discipline strategies support AbbVie’s long-range Strategic Investment objectives, strategic investment programs and adoption of new technologies across future manufacturing platforms. Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact. Strategic New Technology and Capital Investment Support: Provide engineering leadership for strategic capital investments, including new biologics drug substance and cell and gene therapy facility builds, technology platform deployments, new production capabilities, strategic capacity projects and lifecycle technology upgrades. Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site / platform planning activities for biologics drug substance and cell and gene therapy assets. Partner with Strategic Investments and project leadership to ensure technical assumptions, deliverables, risks and resource needs are integrated into capital program plans. Apply Strategic Investment lessons learned and standards to improve project quality, speed, reliability and readiness across the portfolio. Technical Leadership and Delivery: Lead or support technical decision-making for biologics drug substance and cell and gene therapy process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery across multiple manufacturing sites, capital projects and technology platforms. Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness. Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders. Drive timely resolution of technical issues and ensure suitable escalation when decisions have broader project, network or business impact. Cross-Functional Integration: Partner with Strategic Investments, manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain, finance and related engineering disciplines. Ensure discipline decisions are integrated with biologics drug substance and cell and gene therapy manufacturing strategy, network capacity, technology platform deployment, regulatory expectations and site handover needs. Facilitate collaboration across Strategic Investments, sites and project teams to avoid fragmented solutions and drive consistency across the strategic capital portfolio. Represent Strategic Investment in technical reviews, project forums and risk discussions relevant to assigned scope. Capability Building and Continuous Improvement: Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects. Build capability through coaching, mentoring, technical review discipline and development of reusable engineering practices. Promote a culture of engineering excellence, safety, quality, reliability, collaboration, accountability and proactive risk management. Support continuous improvement of Strategic Investment standards, templates, knowledge management and project delivery approaches. Strategic Investment Leadership Expectations: Collaborate across Strategic Investments to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives. Promote consistency, quality, reliability, sustainability and project delivery performance across regions, sites and capital projects. Support long-range manufacturing strategy, strategic investment planning and Strategic Investment capability development. Build technical capability through coaching, mentoring, standards governance, knowledge management and cross-functional collaboration. Stakeholder Interfaces Strategic Investments: Investment planning, portfolio alignment, technical assumptions, front-end engineering, biologics drug substance and cell and gene therapy technology deployment standards and strategic capital program support. Manufacturing Sites and Operations: Network needs, site readiness, operability, maintainability, startup, handover and operational performance support. Quality, Validation / CQV and EHS: Compliance expectations, validation strategy, qualification readiness, safety, risk review and inspection readiness interfaces. Strategic Investment Disciplines: Cross-discipline technical integration, standards, design reviews, technical issue resolution and lessons learned. External Engineering Partners, EPCM Firms, Vendors and OEMs: Technical oversight, deliverable review, issue escalation,