Senior Associate Manufacturing - United States
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Under minimal supervision, the Senior Associate will perform operations in the Purification area on A shift (rotating day shift). Employee will provide technical leadership to the team under the direction of the Purification manager. All operations will be performed according to Standard Operating Procedures (SOPs). Employee will perform and monitor critical processes, execute routine and non-routine protocols, and regularly draft and revise documents such as Manufacturing SOPs, test plans, and technical reports. Employee will also perform complex troubleshooting and assist in the review of documentation for assigned functions. Employee will routinely assume the responsibilities of shift lead to delegate and assign day-to-day operations, tasks, and documentation review. They will participate in cross-functional teams and represent the Purification group. Employee will have the responsibility of owning NC/CAPA’s and Change Control records as required. In addition, employee will identify, recommend, and implement improvements related to routine functions.
Master’s degree OR
Bachelor’s degree and 2 years of Manufacturing and Operations experience OR
Associate’s degree and 6 years of Manufacturing and Operations experience OR
High school diploma / GED and 8 years of Manufacturing and Operations experience
Strong working knowledge of large scale Purification operations, chromatography, TFF, aseptic processing, as well as MFG WIP lab equipment and computers such as Endosafe PTS, and SOLO VPE.
Ability to interpret and apply GMP operations and equipment knowledge to troubleshoot, assist in investigations, and provide recommended solutions
Demonstrated ability to lead teams and delegate tasks to ensure day-to-day operations success
Demonstrated project management skills and presentation skills and the ability to drive deliverables (such as document revisions or project tasks) to meet project deadlines
LIMS and Werum experience
Experienced with EDMQ and document revision process
Delta V, RDs, and the PI system experience
Strong analytical and aseptic skills with a thorough understanding of analytical methods utilized in the manufacturing area
Strong technical writing capability with Trackwise access
Mechanical ability and expertise
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
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 advanced 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 leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.