Bioanalytical Portfolio Scientist

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** Career Category
** Research####
** Job Description**## 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.
** Bioanalytical Portfolio Scientist
**** 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  Bioanalytical Scientist is responsible for oversight of the outsourced bioanalytical phases of studies governed by applicable GLP/GCP principles. Individuals in this role will provide scientific and technical oversight of immunogenicity bioanalytical activities, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, conducted by external contract research organizations (CROs).

Ensures adherence to validated methods, data integrity standards, study protocols, and applicable regulatory expectations. The ideal candidate will have a strong background of method development, validation, and troubleshooting, combined with excellent communication skills. This role is well suited for scientists who understand the dynamic of utilizing an externalized workforce and who thrive working with others in a collaborative manner.
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* Key Responsibilities:

*** Provides scientific and technical oversight for the transfer, validation, and execution of immunogenicity assays, including anti-drug antibody (ADA) and cell based or non-cell based neutralizing antibody (NAb) assays, ensuring adherence to sponsor requirements and current regulatory expectations, industry best practices, and applicable scientific guidance.
* Leads the transfer and validation of assays at external CROs
* Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the immunogenicity methods to ensure successful assay transfer and validation
* Monitors assay performance over time and provides input for troubleshooting and continuous improvement efforts
* Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification of reagents and reference material
* Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and current regulatory guidance
* Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure
* Provides subject matter expertise during supplier evaluation and monitoring activities
* Follows and contributes to guidance documents and SOPs
* Supports regulatory activities
** 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 leader with these qualifications.
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* Basic Qualifications:

** Doctorate degreeORMaster's degree and 2 years of regulated scientific laboratory experienceORBachelor's degree and 4 years of regulated scientific laboratory experience
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* Preferred Qualifications:

*** Demonstrated expertise in Immunoassay development, validation, and troubleshooting for ADA and NAb (cell based or non-cell based) assays
* Knowledgeable on current regulatory expectations, industry best practices, and applicable scientific guidance
* Experienced in working with CROs
* Project and people management
* Process management and planning skills
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