Process Development Associate – Large Molecule Release Testing jobs in United States
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Amgen · 1 day ago

Process Development Associate – Large Molecule Release Testing

Amgen is a biotechnology company focused on serving patients with serious illnesses. The Process Development Associate role involves supporting large molecule release testing and collaborating with cross-functional teams to ensure quality in the development of therapies.

BiotechnologyHealth CareManufacturingPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Cell culture maintenance, reagents/media/buffer preparation, and relevant support
Routine laboratory maintenance such as restocking, ordering, and assistance in safety actions and audit readiness
Performing cell-based assays, binding assays, ELISA and qPCR assays etc
Generating robust and reliable data, organizing and reporting data in a validated system under minimal direction
Supporting method hand-off and troubleshooting
Maintaining and updating monthly Work Order (WO) tracking for PM and calibration activities using Maximo
Managing critical reagent extensions by reviewing monthly needs, submitting requests with supporting assay data, and updating COA
Managing reagents freezer inventory through detailed manual counts and maintenance of inventory tracking records
Coordinating monthly pipette calibration, including collection, verification of WO closure, and initiation of HLEE investigations for out-of-tolerance results

Qualification

Cell cultureCell-based bioassayImmunoassaysQPCRAnalytical method developmentGxP regulationsDocumentation skillsCommunication skillsAttention to detail

Required

High school diploma / GED and 4 years of Scientific experience OR
Associate's degree and 2 years of Scientific experience OR
Bachelor's degree

Preferred

B.S. or M.S. Degree in Cell Biology, Molecular Biology, Biomedical Engineering, Biochemistry or related technical subject area
Demonstrated ability in the biotech industry, including but not limited to GxP regulations
Experience in cell culture, cell-based bioassay, immunoassays, and qPCR etc
Experience developing, qualifying, and testing analytical methods
Excellent documentation skills, including an understanding of GxP requirements
Excellent communication (oral and written) skills and attention to detail

Benefits

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.

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