Sr Associate R&D Operations

1 month ago

Washington, Washington, D.C., United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 OperationsLive

What you will do

Lets do this. Lets 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 positions 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 strategyPerform 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 activitiesAct as escalation point to manage informed consent questions related to biospecimens from Institutional Review Boards/Ethics committeesSupport biospecimen, data, and consent transfers from various vendorsIdentify process gaps in biobank management and make recommendations for continuous improvementProvide biobanking project management support including participating in, or initiating, project meetings with applicable stakeholders, creating and updating relevant trackers, and monitoring milestonesWinWhat 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:Masters degree OR Bachelors degree & 2 years of industry experience in clinical trials and/or biospecimen managementOr Associates degree & 6 years of industry experience in clinical trials and/or biospecimen managementOr 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 laboratoriesKnowledge and functional experience in R&D, particularly specimen management and biobankingKnowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trialsEvidence of project management skillsExceptional verbal and written communication skillsKnowledge of informed consent regulations related to biospecimensExperience 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 relationshipsExcellent interpersonal, organizational, and critical thinking skills, with keen attention to detailThriveWhat 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. 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.

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