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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Associate Manufacturing-Days

Live

What you will do

Let’s do this. Let’s change the world. In this vital role hands-on role in one of the two manufacturing facilities on site at Amgen Rhode Island. Successful candidates will join either the AR5 team, focused on ongoing, high-volume production, or the AR30 team, focused on operational readiness and start-up. Qualifications for this role are the same in both facilities.

The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7AM-7PM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.

There are multiple openings for this position.

Under minimal supervision the Senior Associate will perform and monitor critical processes, execute 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.

• Lead manufacturing operations on the production floor.
• 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.

Win

What we expect of you

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

Basic Qualifications:

• Master’s degree
• Bachelor’s degree and 2 years of Manufacturing or Operations experience or
• Associate’s degree and 6 years of Manufacturing or Operations experience or
• High school diploma / GED and 8 years of Manufacturing or Operations experience

Preferred Qualifications:

• Bachelor’s degree in Science or Engineering
• Knowledge of cell culture operations and bioreactors or purification operations including aseptic processing
• Experience operating Single-use-Systems
• Knowledge of DeltaV (for process control) and windows-based software
• CFR and Regulatory knowledge
• Mechanical aptitude with ability and expertise
• Ability to independently collaborate with outside resources
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods and equipment for manufacturing area
• Demonstrated technical writing capability
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Troubleshooting skills on process equipment
• Ability to lead teams

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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