Immunogenicity - Principal Scientist

Career Category

Scientific

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.

Immunogenicity - Principal Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide immunogenicity support for our protein therapeutic pipeline. In this role, the individual will provide project and scientific oversight of the immunogenicity component of drug development for a diverse portfolio of Amgen product candidates, including biosimilars. In addition, the individual will work closely with Clinical Development team members across sites and functions including Safety, Process Development, Biomarkers, Toxicology, and Bioanalytical as well as Therapeutic Discovery.

• Represent Clinical Immunology on product teams

• Author key regulatory, clinical study, and technical documents

• Interpret and present immune response data and the potential clinical impact to teams

• Ability to work independently and lead productive cross-functional collaborations

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 scientist with these qualifications.

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 2 years of relevant experience OR

• Master’s degree and 5 years of relevant experience OR

• Bachelor’s degree and 7 years of relevant experience

Preferred Qualifications:

• Doctorate (Ph.D.) and proven industry experience in immunogenicity

• Demonstrated publication record on the topic of immunogenicity

• In-depth understanding of the innate and adaptive immune system, excellent scientific thinking and problem solving

• Detailed knowledge of various bioanalytical assays used to measure the immune response

• Accomplished in the clinical development of biologic drugs or vaccines

• Knowledge of immunogenicity risk assessment related to quality attributes

• Experience with global regulatory guidelines related to immunogenicity assessment

• Excellent communication skills and ability to influence and lead cross-functional teams

• High degree of flexibility to adapt to different projects and shifting priorities

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-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact w