HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Bioanalytical Portfolio Scientist - ADA

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as the technical subject matter expert for outsourced methods and will be responsible to ensure adequate method validation and optimal method performance at CROs.

The Bioanalytical Portfolio Scientist manages the day-to-day scientific/technical activity at contract labs. The successful candidate will have an excellent understanding of method development, validation, and troubleshooting in the area of immunogenicity, combined with excellent communication skills. This position is ideal for a scientist who seeks to learn more about externalized work and enjoys working with others in a collaborative manner.

• Provides scientific technical expertise to ensure the success of method transfers and optimal method performance at Contract Research Organizations (CROs)

• Collaborates closely with internal BA subject matter experts to understand critical attributes of the method to ensure successful transfer and long term performance

• Collaborates closely with Project Coordinators to foster a cohesive relationship and oversee late-stage programs effectively

• Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification/bridging of reagents and reference material

• Conducts scientific monitoring of production runs for appropriateness of assay cut points, aggregate ADA incidence for ABPs, etc

• Monitors quality of method performance over time and provides input for troubleshooting events

• Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure

• Provides subject matter expertise during supplier evaluation and monitoring activities

• Follows and contributes to guidance documents and SOPs

• Supports regulatory activities

Win

What we expect of you

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

Basic Qualifications:

• 0+ Years w/ Relevant PhD, PharmD, MD, or equivalent [and relevant post-doc where applicable]

• 2+ Years w/ Relevant MS or equivalent

• 4+ Years w/ Relevant BS or equivalent

And

• Excellent communication skills

• Strong project management experience

• Fluency in English, both in written and oral communication

• Expertise in ADA assays

Preferred Qualifications:

• Method development and validation expertise

• Experienced in working with CROs

• Scientific technical expertise in immunogenicity

• Project and people management

• Process management and planning skills

• Excellent written and verbal communication skills

• Collaborates, negotiates and persuades others, both internally and externally

• Openly promotes cooperation across the organization

• Project and issue management skills

• Drives for results; delivers processes and outcomes of the highest quality

• Consistently communicates in a manner that is appropriate to the situation

Thrive

What you can expect of us

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

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.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns

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

Apply now

for a career that defies imagination

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

careers.amgen.com

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.