Senior Manager, Operations Lead (Assembly and Packaging)

Genentech•Cary, NC

7d•$116,900 - $217,100•Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products. The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028. Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. The Opportunity: We're seeking a highly experienced and strategic Operations Lead to play a pivotal role in ensuring safe, cost-effective, and efficient device assembly and packaging operations ns, while maintaining compliance with cGMPs, regulatory guidelines from Health Authorities, and Genentech quality policies.During the project phase, you will be an integral member of the User Team and will provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs. In partnership with the Engineering and the start-up project (user) team, you will collaborate with our partner organizations (Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical and operational design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility. This role specifically is about ensuring validation and operational readiness of the facility’s device assembly and packaging lines. Following the go-live of the facility, you will transition into a routine position with responsibilities of daily manufacturing operation. This role requires you to be onsite fill time, initially at the Genentech project office before transitioning on-site once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. During this time: You will support the project leadership and co-lead project teams thereby driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line to meet product and cGMP/regulatory requirements. You will champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management. This also includes provision and realization of creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects. Together with the suppliers and contractors, you will build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process. You will foster a positive safety culture in which no one gets hurt and ensure the integration of environmental health, safety, and security into the business and manufacturing processes, systems, and programs while reporting safety and environmental incidents within one’s functional area. You understand the bigger picture of the project and large volume low cost manufacturing as part of the CVRM disease area and how Pharma Technical (PT) contributes to it. You will work closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals. You will effectively partner with and influence stakeholders across the broader organization without formal authority, and drive technical decisions balancing project, product, quality/regulatory and operations views. You will provide knowledge and training on complex process and equipment technologies to all required partners. You will provide training materials and training for people joining the organization. You will act as a coach for colleagues with less experience and help them develop skills/expertise. You will support the organizational design for Device Assembly and Packaging to align with the various phases of the project and long term operations. Following transition to steady state manufacturing, you will: Possess extended technical knowledge and industrial standards in device assembly and packaging control strategy, qualification, and process validation, as well as facility/asset expertise to manage and drive complex problem solving and/or business improvement. Lead Specialists, and strategic leaders in the Assembly and Packaging areas with the focus on team leadership, development, and accountability, along with cross-functional collaboration and issue resolution. Help build a pipeline of aseptic processing leaders to ensure the future success of Holly Springs. Coach and develop, and lead Process Unit Leads (PULs) in all aspects of daily assembly and packaging operations.. Collaborate with Master Scheduling resources to efficiently load production, considering risks and opportunities, and optimize the use of assembly and packaging assets by working with support groups to maximize the utilization. Develop, implement, and optimize assembly and packaging business processes at a plant level, establishing standards and best practices to ensure safe, cost-effective, and efficient operations Participate in the development of production, productivity, and financial goals, ensuring site goals are met, while driving continuous improvement initiatives to increase the operating effectiveness of the organization Collaborate effectively with cross-functional teams and departments to enable progress across the organization, demonstrating exceptional communication skills to facilitate effective teamwork and engagement, while representing the Assembly and Packaging departments in necessary engagements Apply strategic thinking and a systems approach to anticipate business risks and drive execution, while demonstrating a comprehensive understanding of the broader business context, including safety, finance, and interdependencies, and exemplifying agile leadership roles of visionary, architect, coach, and catalyst (VACC)

Requirements

Bachelor’s degree in a science or engineering discipline.
8+ years of progressive experience in the pharmaceutical industry.
Experience in device assembly and packaging operations.
Skilled with coaching, mentoring, and inspiring others.
Exceptional interpersonal skills and strong communication abilities.
Successful track record of working collaboratively with internal and external teams, partners, suppliers, and customers.
Strong knowledge of FDA and EMEA guidelines and cGMP's for Manufacturing Parenteral Drug Products, including validation requirements.
Proficiency in working with validated change management, discrepancy management, inventory management, and production control systems.
Proficiency in Lean Six Sigma methodologies and a mindset focused on continuous improvement.

Nice To Haves

Agile leadership roles of visionary, architect, coach, and catalyst (VACC)

Responsibilities

Provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs during the project phase.
Collaborate with partner organizations (Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical and operational design, testing, qualification, validation, and start-up of a new Drug Product Fill and Finish facility.
Ensure validation and operational readiness of the facility’s device assembly and packaging lines.
Transition into a routine position with responsibilities of daily manufacturing operation following the go-live of the facility.
Support project leadership and co-lead project teams to drive optimal greenfield facility and operations design for high manufacturing efficiency and quality.
Champion project parts, justify goals towards management, and realize creative ideas to drive business and project efficiency.
Build required processes, documents, and tests with suppliers and contractors to transition design plans into a functioning, approved manufacturing process.
Foster a positive safety culture and ensure integration of environmental health, safety, and security into business and manufacturing processes.
Understand the project's bigger picture and its contribution to the CVRM disease area and Pharma Technical (PT).
Partner with and influence stakeholders across the organization without formal authority, driving technical decisions.
Provide knowledge and training on complex process and equipment technologies, including training materials and coaching for colleagues.
Support the organizational design for Device Assembly and Packaging.
Possess extended technical knowledge and industrial standards in device assembly and packaging control strategy, qualification, and process validation.
Lead Specialists and strategic leaders in Assembly and Packaging areas, focusing on team leadership, development, accountability, and cross-functional collaboration.
Coach and develop Process Unit Leads (PULs) in daily assembly and packaging operations.
Collaborate with Master Scheduling resources to efficiently load production and optimize asset utilization.
Develop, implement, and optimize assembly and packaging business processes, establishing standards and best practices.
Participate in the development of production, productivity, and financial goals, driving continuous improvement initiatives.
Collaborate effectively with cross-functional teams and departments, representing Assembly and Packaging departments.
Apply strategic thinking and a systems approach to anticipate business risks and drive execution.