Sr. Manager, Biobank

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this. Lets change the this vital role you will be part of the larger corporate mission of bringing medicines to patients with unmet medical needs every 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. Some of the positions key responsibilities include participating in the following activities:

• 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

What we expect of you

We are all different yet we all use our unique contributions to serve patients. To achieve this the Sr. Manager professional we seek is a creative problem solver who can deliver meaningful results that keenly drive productivity and efficiency with these qualifications:

Basic Qualifications:

• Doctorate degree PhD OR PharmD OR MD and 3 years of industry experience in clinical trials and/or biospecimen management OR
• Masters degree and 6 years of industry experience in clinical trials and/or biospecimen management OR
• Bachelors degree and 8 years of industry experience in clinical trials and/or biospecimen management

Preferred Qualifications:

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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

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.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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.

Salary Range