Career Category

Scientific

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Bioanalytical Outsourcing Sr Manager

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 is responsible to ensure adequate method validation and optimal method performance at CROs.

The Bioanalytical Outsourcing Sr Manager also provides ongoing training to the Test Site Coordinators who lead the day-to-day activity at contract labs. The successful candidate will have an excellent understanding of method development, validation, and troubleshooting in the area of immunogenicity, and quantitative LBA and LC-MS bioanalysis, 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 CROs
• Responsible for forecasting upcoming assay transfers to Supplier Performance Management as well as any upcoming portfolio impact to Test Site Coordinator resources
• Accountable for review of analytical plans, protocol and reports, method lifecycle management including reagents and reference material
• Conducts scientific monitoring of production runs for appropriateness of assay cut points, aggregate ADA incidence for ABPs, etc
• Assesses in-licensed programs for method robustness, identifies need for any additional development, identifies most suitable CRO
• Provides subject matter expertise during supplier evaluation and monitoring activities
• Responsible for implementation of BioLIMS at CROs
• Provides training for the Test Site Coordinators (processes and guidance)
• Controls TSCs to act according to the guidance documents
• Supports regulatory filing questions (RTQs)

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

• Doctorate degree & 2 years of regulated commercial scientific laboratory experience OR
• Master’s degree & 6 years of regulated commercial scientific laboratory experience OR
• Bachelor’s degree & 8 years of regulated commercial scientific laboratory experience OR
• Associate’s degree & 10years of regulated commercial scientific laboratory experience OR
• High school diploma / GED and 12 years of experience of regulated commercial scientific laboratory experience

Preferred Qualifications

• Expertise in PK or ADA assays
• Method validation expertise
• Experienced in working with CROs
• Experience in people management
• Scientific technical expertise in Translational Sciences or Discovery Research specialty area
• Process expert in method development and validation
• 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
• Excellent project 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.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.