Manager Manufacturing Programs

Career Category

Manufacturing

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manager Manufacturing

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of the Manufacturing Programs team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA, deviation investigations, and optimization/implementation of single use technologies. The position is within the drug substance supply organization, a dynamic environment and an important launch point for Amgen’s pipeline products. The plants we support manufacture drug substances at all phases of clinical trials through commercial production.

We are seeking an experienced Manager in drug substance technical operations to lead a team of subject matter experts.

The applicant should have experience managing people, projects, leading/performing technology development activities and characterization efforts. A significant amount of time will be spent working on a collaborative team to identify appropriate corrective/preventive actions and implementing them. Some ‘hands-on’ work on the plant floor executing runs and experiments, working with large-scale equipment, analyzing and summarizing data findings will be required. Additional activities will include defining and documenting operation practices, ensuring documentation accurately reflects operations performed, implementing area improvements, commissioning equipment, design of experiments, effectively communicating findings and participating in operations meetings.

Responsibilities include:

• Leading a team of manufacturing specialists, subject matter experts in upstream manufacturing.
• Demonstrating strategic problem-solving skills and champion continual improvement.
• Managing sophisticated projects using project management skills.
• Lead operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Provide assessment and advice on process impact for changes
• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
• Writing validation protocols and reports in support of cleaning validation, equipment commissioning, qualification, and change management.
• Applying sophisticated process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the detailed delivery of new technologies into the plant.
• Handling Quality Records, such as CCMS, CAPA, and deviations.
• Drafting and revising GMP manufacturing documents (SOPs, Forms)

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications.

Basic Qualifications:

• Doctorate degree OR
• Master’s degree and 3 years of manufacturing and operations experience OR
• Bachelor’s degree and 5 years of manufacturing and operations experience OR
• Associate’s degree and 10 years of manufacturing and operations experience OR
• High school diploma / GED and 12 years of manufacturing and operations experience

In addition to meeting at least one of the above requirements, you must have 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

Preferred Qualifications:

• Degree in Engineering or Life Sciences
• Experience in GMP Technical Support roles, GMP operations, Engineering, or Process Development
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas

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