Bioanalytical Portfolio Scientist

Initial Therapeutics, Inc.; Washington (District of Columbia); On-site; USD 120,000 - 190,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Bioanalytical Portfolio Scientist to act as the technical SME for outsourced immunogenicity assays, ensuring validation and optimal performance at CROs.

The ideal candidate has strong experience with ADA and NAb assays and a proven track record in method development and troubleshooting. The role requires collaboration with internal experts and adherence to GLP/GCP standards.

Qualifications

• Doctorate or equivalent with regulated lab experience.
• Experience with immunogenicity assays (ADA/NAb) preferred.
• Experience working with CROs and regulatory expectations.

Responsibilities

• Provide scientific and technical oversight for transfer, validation, and execution of immunogenicity assays at CROs.
• Lead transfer and validation of assays at external CROs.
• Monitor assay performance and drive continuous improvement.

Skills

Immunoassay expertise

CRO collaboration

Project management

Communication skills

Regulatory knowledge

Education

Doctorate degree

Masters degree with 2 years regulated lab experience

Bachelor's degree with 4 years regulated lab experience

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.

Bioanalytical Portfolio Scientist

What you will do

Lets do this. Lets 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
• Masters degree and 2 years of regulated scientific laboratory experience
• Bachelors 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, 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.

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.

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.