生物分析组合科学家
Bioanalytical Portfolio Scientist
### **职业类别**
研究
### **职位描述**
### 加入安进的患者服务使命
在安进，如果你觉得自己是更大事业的一部分，那确实如此。我们共同的使命——为患有严重疾病患者服务——推动着我们所做的每一件事。
自1980年以来，我们在对抗世界上最难治愈的疾病方面，帮助开创了生物技术领域。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年影响数百万患者。安进正在推进广泛的药物管线，用于治疗癌症、心脏病、炎症性疾病、罕见病以及肥胖及其相关疾病。作为安进团队的一员，你将帮助对患者的生活产生持久的影响，同时进行研究、制造和交付创新药物，帮助人们过上更长、更充实、更幸福的生活。
我们获奖的文化具有协作性、创新性和基于科学的特点。如果你热衷于挑战，并能把握其中的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生命，同时改变你的职业生涯。
**生物分析组合科学家**
**你将负责的工作**
让我们一起行动，改变世界。在这个关键角色中，你将作为外包方法的技术专家，负责确保合同研究组织（CRO）中的方法验证充分且方法性能最佳。
生物分析科学家负责监督受适用GLP/GCP原则管理的研究的外包生物分析阶段。该职位的人员将对由外部合同研究组织（CRO）进行的免疫原性生物分析活动提供科学和技术监督，包括抗药物抗体（ADA）和中和抗体（NAb）检测。确保符合已验证的方法、数据完整性标准、研究方案和相关监管要求。理想的候选人应具备方法开发、验证和故障排除的扎实背景，以及出色的沟通能力。这个职位适合那些了解利用外部劳动力动态，并能在协作环境中与他人共事的科学家。
**主要职责：**
- 为免疫原性检测的转移、验证和执行提供科学和技术监督，包括抗药物抗体（ADA）和
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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 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 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.
**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.
**Basic Qualifications:**
Doctorate degree
OR
Master’s degree and 2 years of regulated scientific laboratory experience
OR
Bachelor’s degree and 4 years of regulated scientific laboratory experience
**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
- 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 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, 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.
### **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, 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.com**
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
### **External/Internal postings:**
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.
### **Internal only posting (or Pre-ID candidate):**
Amgen anticipates accepting applications until 1 week before the posting; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.
### 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.
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**Salary Range**
109,020.15USD -147,497.85 USD