Process Development Scientist – Large Molecule Release Testing (LMRT)

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.

Process Development Scientist – Large Molecule Release Testing (LMRT)

What you will do

Let’s do this! Let’s change the world!

In this vital role in a phase-appropriate GMP setting, you will support lot release and stability study sample testing of early phase Tox and GMP materials in Large Molecule Release Testing (LMRT) labs using bioassays, immunoassays and qPCR under cGMP regulations.

• Partner with the development team and other parts of LMRT to deliver high quality results for lot release and stability testing in a timely and compliant fashion

• Expected to complete product lot release and stability sample testing within defined timeline and with low invalid rates

• Ensure cGMP compliance requirements are met in day-to-day work for audit readiness

• Provide supervision, training, and mentoring to staff

• Generate, document, analyze, and provide critical review and approval of analytical data to support product release and stability, investigations, and regulatory submissions

• Lead analytical method hand-offs, perform method co-qualifications and assay troubleshooting to ensure GMP testing readiness

• Provide support for cell line management, critical equipment monitoring, critical reagent management, inventory tracking and expiry extensions

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 an individual with these qualifications.

Basic Qualifications:

• Bachelor’s degree and 4 years of relevant lab-based science & GMP experience OR

• Master’s degree and 2 years of relevant lab-based science & GMP experience OR

• Doctorate degree

Preferred Qualifications:

• Strong experience and expertise in cell culture, binding assay, cell-based bioassay, ELISA, and qPCR

• Strong experience in GMP environment and adherence to good documentation practices

• Strong troubleshooting and problem-solving skills with attention to details

• Previous experience leading projects and/or managing teams

• Highly self-driven to ensure project deliverables are met within prescribed timelines

• Great teamwork, ability to collaborate well cross-functionally

• Excellent communication (oral and written) skills

What you can expect from 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-term incentives

• Award-winning time-off p