Senior Manager Manufacturing Support

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Join Amgens Mission of Serving Patients. At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

• Lead and manage the manufacturing Process Owner team that provides technical, project, emergency response, and troubleshooting support to the manufacturing areas.
• Lead the relevant process owner team to achieve plant goals and objectives.
• Ensure consistent global operational practices are implemented through alignment with standards and continued evaluation of practices by engaging in relevant global networks and teams.
• Explain Assembly and Packaging process to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.).
• Ensure process owner has the ability to own Deviations, Change Controls, CAPAs, CAPA EVs and CDOCS documents (Quality System records & documents).
• Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, etc) that are owned by the process owners.
• Support the plant in the project approval, prioritization and implementation process.
• Develop functional area metrics to support benchmarking of site, global, and industry. Develop improvement strategies based on the benchmarking data.
• Provide technical direction to the team.
• Provide on-the-floor and hands-on support in complex troubleshooting exercises.

• Lead in the development of the Process Owners long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals.
• Ensure the coordination and goal alignment of functional area and plant production operations.
• Participate in Plant Level Work Center Team (WCT) meetings and Lead Process Owners daily WCT.
• Develop plans and ensure adequate staffing and knowledge to ensure Target Dates for the teams work (NPI, CAPA, Change Control, SOP and E  revision, risk assessments, etc.) are met.
• Develop, control, maintain, track, justify and stay within the functional area budget.

• Collaborate with and serve as department liaison to support other organizations (Manufacturing, QA, F&E, PD, IS, etc.).
• Resolve issues between manufacturing, quality and maintenance organizations.

• Ensure Assembly and Packaging practices (processes & methods) and policies align with external regulatory requirements and internal corporate and site guidelines and procedures.
• Connect with Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance.
• Develop, approve, establish and ensure practices and policies are consistent.
• Main Manufacturing point of contact in regulatory audits.
• Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area.

• Coach, mentor and ensure the development of supervisors and staff.
• Partner with HR to recruit, retain and empower staff.
• Ensure an ongoing organizational structure capable of adapting to changing business needs.
• Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs.
• Ensure functional area staff exemplifies the Amgen Values & Behaviors.
• Ensure an executable Succession Plan is in place for the relevant functional area.

We are all different, yet we all use our unique contributions to serve patients. The Sr Manager Manufacturing Support professional we seek is a leader with these qualifications.

• Doctorate degree and 2 years of manufacturing support experience
• Masters degree and 6 years of manufacturing support experience
• Bachelors degree and 8 years of manufacturing support experience
• Associates degree and 10 years of manufacturing support experience
• High school diploma / GED and 12 years of manufacturing support experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• Educational…