User Team Lead, HTO Expansion (Aseptic Filling Operations)

The Opportunity

As a member of the HTO Expansion Project Leadership Team, you will report to the HTO Site User Team Lead and spearhead efforts to expand Hillsboro site manufacturing capacity from start-up of new filling assets to commercialize operations for new products. Project Cascadia concentrates on enhanced downstream drug product capabilities encompassing nested prefilled syringe (nPFS) aseptic filling operations, device assembly, and final packaging. You will manage the aseptic filling operations Cascadia project to ensure all programs are delivered on time. You will align the site expansion with existing operations and corporate operating principles, pharma vision and network strategies. Your immediate focus will be facilitating the successful Operational startup of the aseptic filling facility with a vision to achieving the long-term strategic goals for HTO to enable full deployment of new assets and new products to our site. You will work in close collaboration with global leaders in the network, peers in the HTO Manufacturing Leadership Team, and the PT Manufacturing team. In addition, you will drive the translation of network plans to the site level and vice versa. You will gain a deep understanding of long-term business needs, identifying people and operational performance gaps, and actively shaping strategic priorities in alignment with site and network leadership. Your focus will involve leading the development and implementation of management strategies and goals for the expansion of the site.

• Lead and coordinate the aseptic filling operational startup of the expansion
• Establish, onboard and lead the user team members with all required site functions like production, maintenance, reliability, commissioning, coordinate their activities and acquire the necessary resources and work as one project team
• Form a partnership with the capex project management team to deliver the site expansion project
• Represent site perspective regarding project deliverables during the Basic Design, Detailed Design, qualification and ramp up phases of the project, providing the necessary information and knowledge needed to design and test associated equipment
• Proactively provide process requirements and coordinate production needs and impacts, establishing a transition strategy of new technology integrating into the existing site to ensure success of new operations while operating the HTO commercial business successfully
• Act as a crucial thought partner to the HTO Site and Manufacturing Leadership Team
• Ensure site alignment with key stakeholders across the Roche Network and local HTO partners
• Partner with site and network people and culture leaders to drive site workforce strategy to enable full deployment of new filling assets and new products to our site
• Support efforts to cultivate an environment that makes Genentech/Roche and the site a great place to work
• Actively shape organizational operating models
• Deliver insights and recommendations that accelerate transformation and strategy
• Lead change on the site level and role model our Leadership Commitments
• Represent the fill finish end user team from design through implementation

Who you are

• You have a Bachelor's Degree (engineering or science) - Graduate Degree or MBA is preferred
• Please note this role can be hired either at the SE7 or SE8 level. For the SE7 level position, you have 8 or more years work experience in the pharmaceutical or related industry with at least 4 or more years of people and project management experience and 4 or more years' in manufacturing or quality management experience. For the SE8 level position, you have 12 or more years work experience in the pharmaceutical or related industry with at least 6 or more years of people and project management experience and 4 or more years' in manufacturing or quality management experience
• You have experience developing and leading large cross-functional initiatives with risk and complexity which have a broad impact on the organization
• You have strong communication and influencing experience preferably with working across diverse groups/ complex organizations, either through direct leadership of teams and/or indirectly in a matrix leadership role. Includes the ability to anticipate potential challenges and synthesize multiple points of view
• You have operational experience in drug product aseptic filling operations, preferably nPFS filling
• You have demonstrated the ability to thrive in ambiguity, challenging the status quo
• You are a strategic system thinker and have the ability to translate strategies into actionable plans and are able to prioritize and deliver significant project outcomes
• You are able to build high performing teams, networks and engage different stakeholders in an international organization