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Process Development Senior Associate (Attribute Sciences) jobs in United States
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Amgen · 1 day ago

Process Development Senior Associate (Attribute Sciences)

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. The Process Development Senior Associate role involves providing scientific and technical contributions within the Process Development Attribute Sciences department, focusing on analytical testing and support for drug substance manufacturing.
BiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing
Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to chromatography, capillary electrophoresis, and UV-Vis spectroscopy
Execute methods, author reports and ensure safety and compliance for all activities

Qualification

Process DevelopmentAnalytical TechniquesChromatographyCapillary ElectrophoresisMethod ValidationTechnical WritingCommunication SkillsAttention to Detail

Required

High school diploma / GED and 6 years of Process Development / Chemistry or related experience OR
Associate's degree and 4 years of Process Development / Chemistry or related experience OR
Bachelor's degree and 2 years of Process Development / Chemistry or related experience OR
Master's degree

Preferred

Degree in Chemistry or related area
Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing
Strong experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis) and Chromatography (SE and RP))
Experience in method transfers, method validation, method troubleshooting, and complex investigations
Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation
Knowledgeable in analytical method troubleshooting and analysis of product quality attributes related to biological processing
Oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Excellent technical writing skills and attention to details in documents
A self-starter and valuable teammate

Benefits

Competitive and comprehensive Total Rewards Plans

Company

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.

H1B Sponsorship

Amgen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)

Funding

Current Stage
Public Company
Total Funding
$28.5B
2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO

Leadership Team

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Robert Bradway
Chairman and Chief Executive Officer
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Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
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Company data provided by crunchbase