Process Development Senior Associate - Cellular Sciences/Adventitious Agents Control Sciences (AACS)

m, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

PROCESS DEVELOPMENT SENIOR ASSOCIATE - CELLULAR SCIENCES / ADVENTITIOUS AGENTS CONTROL SCIENCES (AACS)

What you will do

Let's do this! Let's change the world! In this vital role you will join our Adventitious Agents Control Sciences (AACS) group to perform molecular assays, and adventitious agents control strategies for various Amgen's pharmaceutical products and will partake in technology development for detection and identification of adventitious agents of any type.

The primary focus will be to provide regulatory, scientific, and technical expertise in adventitious agents and biopharma biosafety testing. This includes contamination investigations, troubleshooting and remediation of analytical methods, and evaluating and onboarding innovative technologies for rapid detection of adventitious agents. Emphasis will be placed on leveraging advanced platforms employing both traditional and modern virological and microbiological methods for the detection of viruses and mycoplasmas.

Responsibilities will include but not limited to:

• Design, develop, optimize, qualify, and/or validate Next-Generation Sequencing (NGS) and nucleic acid testing (NAT) assays.

• Apply Next-Generation Sequencing (NGS) technologies for the detection, identification, and characterization of viral adventitious agents.

• Implement and remediate traditional and modern molecular biology and virology techniques for the rapid detection of adventitious agents, including viruses and mycoplasmas.

• Identify and characterize viruses, bacteria, and fungi using conventional and modern NAT and sequencing-based methodologies.

• Perform mammalian cell culture, virus production, and characterization.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative team-player with these qualifications.

Basic Qualifications:

• Master's degree OR

• Bachelor's degree & 2 years of scientific experience OR

• Associate's degree & 4 years of scientific experience OR

• High school diploma/GED & 6 years of scientific experience

Preferred Qualifications:

• Proficiency with NGS systems such as Illumina and Ion Torrent systems.

• Advanced capability in analyzing NGS datasets using bioinformatics tools and pipelines.

• Expertise in Next-Generation Sequencing (NGS) assay design, development, optimization, qualification, and validation.

• Highly skilled in digital PCR (e.g., QIAcuity) and other NAT systems.

• Experience in virus production, virological assays, and sample preparation techniques.

• Familiarity with adventitious agent testing guidelines and compendial methods, including their application in assay development, validation, and regulatory compliance.

• Deep understanding of cell biology, virology, and associated mathematical and statistical principles.

• Familiarity with Good Laboratory Practices (GLP) and regulatory requirements for assay development and validation.

• Strong statistical and computational skills for interpreting data and generating actionable insights.

• Demonstrated excellence in written and verbal communication, including the ability to author detailed technical reports, develop and revise Standard Operating Procedures (SOPs).

• Skilled in documenting experimental results, creating comprehensive protocols, and ensuring clarity and accuracy in technical documentation, and prepare presentations for diverse audiences.

• Ability to document and present complex scientific findings in a clear and concise manner.

• Collaborative attitude to work effectively as part of a multidisciplinary team.

• Ability to define and implement Design of Experiments (DOE) to evaluate variables and optimize protocols.

• Strong planning, organizational, and project execution skills, ensuring timely delivery of achievements.

• Ability to multitask and prioritize responsibilities in a dynamic research environment.

• Eagerness to learn new scientific concepts, technologies, and methods.

• Ability to quickly adapt to evolving project needs and research goals.

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, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Application deadline

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.

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.

Salary Range
82,396.00 USD - 99,167.00 USD