Senior Associate Manufacturing - Solutions Prep and Upstream Support Process Owner

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. 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 - Solutions Prep and Upstream Support Process Owner

What you will do

Let’s do this. Let’s change the world. In this vital role you will join the manufacturing technical support function in Amgen Rhode Island. Next Generation Bio Manufacturing plant AR30 is responsible for drug substance and the release of Amgen’s commercial product using innovative single use manufacturing platforms and technologies.

Responsibilities include:

• Interact broadly across the site/plant to implement key business deliverables, quality initiatives, and continuous improvement projects

• Support in developing Training Material, SOP's, Electronic Batch Records, Job Hazard Analysis, and Standard Work

• Participate in commissioning and qualification of process equipment

• Facilitate problem solving and root cause investigations in a biotechnology environment

What we expect of you

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

Basic Qualifications:

• High school diploma / 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:

• Single use technology experience

• Solutions Preparation and/or Cell Culture Experience (troubleshooting critical processes)

• Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment (Deviation / Nonconformance investigation writing experience)

• Understanding of analytical methods used for manufacturing area

• Regulatory knowledge and experience with regulatory audits

• Ability to interpret and apply GMP knowledge

• Knowledge of WIP lab equipment and computers, with LIMS access

• Statistical and mathematical skills

• Ability to demonstrate technical writing capability

• Able to demonstrate project management skills and presentation skills

• Ability to understand, apply and evaluate basic chemistry, biology and physical principles

• Experience with Delta V/MES

• Experience with lab equipment/testing

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 step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long