Sr Associate R&D Operations

Career Category

Project Management

Job Description

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.

Sr Associate R&D Operations

Live

What you will do

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

Biological Sample Management and Biobank provides end-to-end biospecimen management for clinical trials. Our team delivers on key initiatives as well as tactical support to ensure our research scientists receive the biospecimens they are responsible for testing.

You will be part of the larger corporate mission of bringing medicines to patients with unmet medical needs every day. In this key role as a Sr. Associate, Biological Sample Management and Biobank, you will come in to help us exceed productivity goals and deliver against our operational goals. Our scale is global and supports our clinical trials around the world. Please join an outstanding team that delivers for our stakeholders!

You will be responsible for supporting biospecimen management and biobank activities for all clinical programs and, through your work, contribute to optimization of cross-functional workstreams related to biospecimens and biobanking. To achieve this, the Sr. Associate is detail-oriented and a creative problem solver who can deliver meaningful results that support efforts around productivity and efficiency. Some of the position’s key responsibilities include participating in the following activities:

• Responsible for management of assigned biobank inventory review, reconciliation, and disposition activities in alignment with informed consent and biobanking strategy
• Perform data entry in the LIMS system to support clinical sample management and biobanking under Good Clinical Practices (GCP)
• Facilitate specimen transfer related to in-license and out-license activities
• Act as escalation point to manage informed consent questions related to biospecimens from Institutional Review Boards/Ethics committees
• Support biospecimen, data, and consent transfers from various vendors
• Identify process gaps in biobank management and make recommendations for continuous improvement
• Provide biobanking project management support including participating in, or initiating, project meetings with applicable stakeholders, creating and updating relevant trackers, and monitoring milestones

Win

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 strong collaborator with these qualifications.

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree & 2 years of industry experience in clinical trials and/or biospecimen management

Or

Associate’s degree & 6 years of industry experience in clinical trials and/or biospecimen management

Or

High school diploma / GED & 8 years of industry experience in clinical trials and/or biospecimen management

Preferred Qualifications:

• Prior work experience (3+ years) in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories
• Knowledge and functional experience in R&D, particularly specimen management and biobanking
• Knowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
• Evidence of project management skills
• Exceptional verbal and written communication skills
• Knowledge of informed consent regulations related to biospecimens
• Experience with Laboratory Information Management Systems (LIMS)
• Experience using document management applications and project management tools (eg. Veeva platform, Smartsheet or similar)
• Ability to develop collaborative internal and external relationships
• Excellent interpersonal, organizational, and critical thinking skills, with keen attention to detail

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 qualifi