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

2+ years
Not Disclosed
10 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Posting Title: Process Development Senior Associate – Cellular Sciences / Adventitious Agents Control Sciences (AACS)

Location: Amgen (location unspecified)
Career Category: Scientific Research / Development
Employee Subgroup: Salaried FT
Country/Region: Global


Amgen Job Description

At Amgen, we’re driven by a shared mission—to serve patients living with serious illnesses. Since 1980, we’ve been pioneers in biotechnology, focusing on Oncology, Inflammation, General Medicine, and Rare Disease to help millions of patients each year. If you are passionate about innovation, challenges, and the opportunity to make a difference in patients' lives, we invite you to join us and help transform the future of healthcare.


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

What You Will Do:

Amgen is seeking a Process Development Senior Associate to join our Adventitious Agents Control Sciences (AACS) team. In this key role, you will help advance our molecular assays and contamination control strategies for our pharmaceutical products. You will also be involved in the development of technologies for the detection and identification of adventitious agents of all types.

Your primary focus will be to provide regulatory, scientific, and technical expertise in biosafety testing, contamination investigations, troubleshooting analytical methods, and evaluating innovative technologies for rapid detection of adventitious agents. Your role will involve both traditional and cutting-edge virological and microbiological methods to detect viruses and mycoplasmas.

Key responsibilities include, but are not limited to:

  • Molecular Assay Development:

    • Design, develop, optimize, qualify, and validate Next-Generation Sequencing (NGS) and nucleic acid testing (NAT) assays.
    • Apply NGS technologies for detection and identification of viral adventitious agents.
    • Utilize traditional and modern molecular biology techniques to enhance detection of viruses and mycoplasmas.
    • Conduct virus production, mammalian cell culture, and characterization.
  • Technology and Process Development:

    • Implement and remediate molecular biology and virology techniques for rapid agent detection.
    • Characterize and identify viruses, bacteria, and fungi using modern NGS and NAT methodologies.
    • Contribute to technology development and regulatory compliance in assay development.
  • Collaboration and Documentation:

    • Work closely with cross-functional teams to integrate new technologies into Amgen’s biosafety testing framework.
    • Document experimental results, prepare technical reports, and develop Standard Operating Procedures (SOPs).
    • Present complex scientific data in a clear, concise manner for diverse audiences.

What We Expect of You:

We are looking for a collaborative, driven, and detail-oriented professional with the following qualifications:

  • Basic Qualifications:

    • Master’s degree in a relevant scientific field
    • 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 (e.g., Illumina, Ion Torrent).
    • Advanced skills in bioinformatics and analyzing NGS datasets.
    • Expertise in NGS assay design, development, optimization, and validation.
    • Skilled in digital PCR and other NAT systems.
    • Experience with virus production, virological assays, and sample preparation techniques.
    • Familiarity with adventitious agent testing guidelines and compendial methods.
    • Strong knowledge of cell biology, virology, and statistical principles.
    • Ability to work with Good Laboratory Practices (GLP) and regulatory standards.
    • Strong statistical and computational skills for data interpretation.
    • Demonstrated excellence in written and verbal communication.

What You Can Expect of Us:

At Amgen, we believe in fostering the growth and well-being of our team members. As we work to develop treatments that make a difference in the lives of patients, we prioritize your professional development and personal growth.

Amgen offers a Total Rewards Plan, including:

  • Comprehensive benefits: Retirement and savings plans, medical, dental, vision coverage, life & disability insurance.
  • Performance-based rewards: Annual bonus programs and stock-based long-term incentives.
  • Time-off plans: Award-winning time-off plans and flexible working arrangements, including remote and hybrid options.

Apply Now

Join Amgen in our mission to help patients live longer, fuller, and healthier lives. Apply today and take the next step in transforming your career.

[Apply Here]


Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other basis protected by applicable law. We ensure reasonable accommodations for individuals with disabilities to participate in the job application or interview process, to perform essential job functions, and to receive other employment benefits. Please contact us to request accommodation.