Career Category

Job Description

Amgen’s Raw Material Centralized Testing Instrumentation Laboratory is seeking an associate laboratory analyst to execute and review analytical testing in our cGMP laboratory. The role will be based out of Amgen Rhode Island and will work under the mentorship of the hiring manager. It is an administrative shift, Monday through Friday.

The Raw Material Centralized Testing team provides analytical expertise in testing raw materials to meet Amgen specifications and ensure a constant supply of raw materials for Amgen products. The laboratory employs a variety of test methodologies that utilizes sophisticated equipment including HPLC, GC and ICPMS. The team provides these crucial services for the entire Amgen production network, to ensure only the highest quality raw materials are used to build products for our patients.

Responsibilities:

• Follow safety guidelines, cGMPs (Good Manufacturing Practices) and other applicable regulatory requirements
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations
• Operate laboratory equipment and instrumentation
• Performs review and approval of assays, documents and records
• Supports Continual Improvement initiatives
• Alerts management of quality, compliance, supply and safety risks
• Participate in laboratory investigations
• Perform general laboratory housekeeping activities
• Completes required assigned training to permit carry through of required tasks
• Performs additional duties as specified by management

Basic Qualifications

Bachelor’s degree

Or

Associate’s degree and 4 years of Quality or Operations experience

Or

High school diploma / GED and 6 years of Quality or Operations experience

Preferred Qualifications

• Professional work experience in a fast-paced, flexible GxP laboratory
• Demonstrated experience with various laboratory practices
• Self-motivated, strong organizational skills and ability to handle multiple tasks at one time with supervision
• Strong interpersonal skills (both written and oral), facilitation and presentation skills
• Demonstrate ability to be flexible and adaptable
• Knowledge of pharmacopoeial testing, USP (United States Pharmacopeia) and PhEUR (European Pharmacopeia).
• Experience with benchtop wet chemistry (color change/precipitation reactions, titrations etc.) or HPLC/GC (high-performance liquid chromatography/gas chromatography) experience

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like sophisticated human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and demonstrates its expertise to strive for solutions that improve health outcomes and spectacularly improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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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, or disability status.