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. 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, 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.

PREFERRED QUALIFICATIONS:

• Educational background in Life Sciences or Engineering
• Availability to support the manufacturing operation on Non Standard Shifts, Nights or Weekends (On call and/or on site) as needed
• Experience with Final Drug Product manufacturing technologies / equipment, specifically Assembly and Packaging manual and automated equipment
• Regulatory knowledge and interactions
• Knowledge of conflict resolution and negotiating skills
• Ability to partner with other departments / functions / areas
• Analytical problem solving
• Considerable organizational skills
• Technical writing and presentation skills.
• Basic project management skills.
• Knowledge of control charting and statistics
• Experience in coaching, mentoring and counseling
• Ability to deal with and manage fast and constant change
• Ability to set goals
• Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately
• Customer satisfaction mentality
• Ample knowledge of cGMP Regulations around Sterile Product Manufacturing, Combination Products and other relevant area regulatory requirements
• Ability to maintain an environment and culture of operational excellence and continuous improvement
• Proven experience implementing a continuous improvement program based on performance monitoring through KPIs
• Desire to create an environment with Diversity, Inclusion and Belonging

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.
In this vital role you will be responsible for leading and managing continuous improvement projects at the AOH Assemble and Packaging Plant. Includes revision of documentation (SOP, PTC, FORM, Manufacturing Procedure), QMS records (Deviation, CAPA, Change Control, CAPA EV), Electronic Batch Records and Risk Assessments. Reporting to the Executive Director Plant Manager, this role will support the other functional areas Assembly and Packaging (Vials, Syringes, Devices), Engineering, Process Development, Quality, Validations, IS, Regulatory and other functions as required. This role is crucial for AOH success, it is a key contributor in AOH daily operation and is considered part of the Leadership Team.