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Process Development Senior Associate - Cellular Sciences/Adventitious Agents Control Sciences

Employer
Amgen
Location
Thousand Oaks, California
Start date
Nov 22, 2024
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Job Details

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. 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.

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

What you will do

Lets do this! Lets 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 Amgens 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:

  • Masters degree OR

  • Bachelors 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, 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, 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.

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

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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