Career CategoryScientific
Job DescriptionScientist, Bioanalytical SciencesWhat you will doLet'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 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.
Key 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
- Supports regulatory activities
What expect of youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:Doctorate degree [and relevant post-doc where applicable]
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
Preferred Qualifications:- 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
What you can expect of usAs 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, we'll 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.careers.amgen.comSalary Range109,020.15USD -147,497.85 USD
