Sr. Manager, Biobank

Amgen•Thousand Oaks, CA

About The Position

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Senior Manager, Biobank What you will do Let’s do this. Let’s change the world. In this vital role 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 Manager, 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 biobank activities for all clinical programs and contribute toward optimizing workstreams functionally throughout the organization as it relates to biospecimens.

Requirements

Doctorate degree PhD OR PharmD OR MD and 3 years of industry experience in clinical trials and/or biospecimen management OR Master’s degree and 6 years of industry experience in clinical trials and/or biospecimen management OR Bachelor’s degree and 8 years of industry experience in clinical trials and/or biospecimen management
Knowledge and functional expertise in R&D, particularly specimen management and biobanking
Knowledge of Good Clinical Practices (GCP), ICH and FDA guidelines for clinical trials
Evidence of strong project management skills
Exceptional verbal and written communication skills and experience navigating a matrixed organization
Experience with informed consent regulations related to biospecimens
Experience with Laboratory Information Management Systems (LIMS)
Working knowledge of document management applications and study planning tools (eg. Planisware, Documentum, Veeva platform, etc)
Ability to develop collaborative internal and external relationships
Excellent interpersonal, organizational, and critical thinking skills

Nice To Haves

7+ years work experience in clinical research setting in Pharmaceutical, Medical Devices, Clinical/Diagnostics areas, and/or contract research laboratories

Responsibilities

Serve as the senior escalation authority for complex informed consent and biospecimen governance matters, providing final interpretation of participant intent and partnering with Institutional Review Boards and Ethics Committees to enable compliant and efficient study start-up
Establish and maintain the enterprise governance framework for informed consent templates related to biospecimen collection, retention, and reuse, ensuring alignment across clinical programs and evolving global regulatory expectations
Lead and develop a multi-layered operating model across internal staff and FSP partners, ensuring appropriate segmentation of transactional, rules-based, and judgment-driven work while driving overall operational performance
Identify systemic gaps across the biospecimen lifecycle and lead cross-functional initiatives to implement scalable solutions that improve cost efficiency, turnaround time, and governance quality
Own the strategic direction of biobank operations, including inventory optimization, long-term storage and disposition strategy, and advancement of key transformation initiatives aligned with the future-state operating model
Set vendor and supplier strategy for long-term storage and biobank services, including selection, performance oversight, and alignment with enterprise cost and capacity planning goals
Provide executive oversight of biospecimen transfer activities supporting in-licensing and out-licensing, ensuring risk mitigation, compliance, and seamless integration with broader R&D transactions
Ensure inspection readiness and governance oversight for nonclinical biospecimen management under GLP, reinforcing quality systems and regulatory compliance expectations
Define and drive capability-building strategy across the biobank function, including training frameworks, escalation pathways, and role clarity to support the evolving governance and program leadership model

Benefits

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 where possible

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume