Specialist Manufacturing

Career Category

Operations

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.

Specialist Manufacturing

What you will do

Let’s do this. Let’s change the world. ARI has three openings for a manufacturing Specialist. In this vital role you will be part of the Manufacturing Product Lifecycle management team. You will report to the manager responsible for New Product Introductions/Product Reintroductions and various Manufacturing support activities necessary for the success of the site production deliverables.

Specific strategic product and process implementations will be led from this position. Examples include cross functional initiatives at site and network, support of product teams for NPIs. Support may include evaluation of processes and capabilities for yield improvement, implementation of new equipment, technology changes aligned with Long Range Plan and support of alternate sourcing activities from a technical perspective to enable supply chain agility.

Key Responsibilities Include:

• Lead and support planning and execution of key initiatives with cross functional teams at the production floor

• Liaison at the floor and with cross function teams to assure program (NPI/PRI) preparation, implementation, sustainment and capture and share lessons learned.

• Provide and analyzes data to support management evaluation of process performance trends

• Provide subject matter expertise for area of responsibility

• Own quality records (change control, CAPA, deviations) and deliver to timelines

• Support AR5/AR30 manufacturing organizations in the prioritization and execution of these activities to maximize plant performance and plant capacity.

• Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements

• Support of front-line managers through on the floor presence

• Own and author critical standard operating procedures and supporting documentation/training.

• Anticipate risk and builds contingencies to help mitigate impact

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 expert problem solver with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Manufacturing or Operations experience OR

• Associate’s degree and 8 years of Manufacturing or Operations experience OR

• Bachelor’s degree and 4 years of Manufacturing or Operations experience OR

• Master’s degree and 2 years of Manufacturing or Operations experience OR

• Doctorate degree

Preferred Qualifications:

• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment

• Strong project management skills with ability to multi-task and function in a dynamic environment

• Excellent communication skills, drive, and sense of urgency

• Demonstrated ability to forge and maintain strong relationships within other functional areas

• Previous experience in manufacturing, quality systems, implementation of new equipment and processes (Harvest, Chromatography, Supply Chain).

• Ability to recommend, judge, and make good decisions in complex situations

• Ability to tactfully and effectively negotiate and influence

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every st