Senior Associate Manufacturing - Days AR30 Purification A shift

Career Category

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. 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.

Senior Associate Manufacturing - Days

What you will do

Let’s do this. Let’s change the world. In this vital role you will perform and monitor critical processes, complete routine qualification and validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, deviations/CAPAs, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the area manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing their home department. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

In this role, you will be expected to work a 12-hour shift (7AM-7PM) on a rotating schedule (A Shift AR30). This includes extra benefits such as overtime, and also getting premium pay for any Sundays worked. The schedule during the initial on-boarding/training phase (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

Responsibilities:

• Lead manufacturing operations on the production floor, according to GMP (Good Manufacturing Practices) standards.

• Ensure all safety and compliance procedures are followed at all times.

• Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.

• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.

• Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.).

• Serve as SME for functional area operations.

• Provide training to manufacturing staff on process and equipment.

• Own deviations and Corrective and Preventive Actions (CAPA).

• Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas.

• Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.

• Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.

• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.

• Participate in the design, development, and implementation of processes in support of the manufacturing floor.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The motivated professional we seek is a great teammate with these qualifications.

Basic Qualifications:

• High School/GED and 4 years of manufacturing or operations work experience OR

• Associate’s degree and 2 years of manufacturing or operations work experience OR

• Bachelor’s Degree and 6 months of manufacturing or operations work experience OR

• Master’s Degree

Preferred Qualifications:

• Bachelor’s degree in Science or Engineering.

• Downstream experience.

• Knowledge of cell culture operations and bioreactors or purification operations including aseptic processing.

• Experience operating Single-use-Systems.

• Knowledge of DeltaV (for process co