Bioanalytical Portfolio Scientist

Amgen • Thousand Oaks, CA

17h

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. 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 at CROs. The Bioanalytical Portfolio 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 bioanalytical activities (including pharmacokinetic [PK] and toxicokinetic [TK] analyses) performed by external contract research organizations (CROs), ensuring adherence to validated methods, data integrity standards, and alignment with study protocols and regulatory requirements. The ideal candidate will have a strong background of method development, validation, and troubleshooting in quantitative ligand-binding assays (LBA) and/or LC-MS bioanalysis, combined with excellent communication skills. This role is well suited for scientists who seek to learn more about externalized work and who thrive working with others in a collaborative manner. Provides scientific and technical oversight for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA) Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method 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/bridging 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a scientist with these qualifications.

Requirements

• Doctorate degree OR Master’s degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience OR Associate’s degree and 8 years of regulated commercial scientific laboratory experience OR High school diploma / GED and 10 years of regulated commercial scientific laboratory experience

Nice To Haves

• Excellent communication skills
• Strong project management experience
• Fluency in English, both in written and oral communication
• Demonstrated expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays
• Knowledgeable on current relevant regulatory guidance/regulations (e.g. FDA, ICH, EMEA, NMPA)
• Experienced in working with CROs
• Project and people management
• Process management and planning skills
• Excellent written and verbal communication skills
• Collaborates, negotiates and persuades others, both internally and externally
• Openly promotes cooperation across the organization
• Project and issue management skills
• Drives for results; delivers processes and outcomes of the highest quality
• Consistently communicates in a manner that is appropriate to the situation

Responsibilities

• Provides scientific and technical oversight for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA)
• Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method 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/bridging 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees