Career Category

Job Description

Amgen Rhode Island is one of the premier biologics drug substance manufacturing sites in the world with a long history of operational excellence and highly successful commercial and clinical operations.

We are looking for a talented candidate to help deliver opportunities for reliability, efficiency, agility and differentiation for the AR5 Manufacturing plant. This individual contributor position interacts broadly across the site to implement key business results, quality initiatives, and continuous improvement projects within the manufacturing area.

Key Responsibilities:

Provide and analyzes data to support management evaluation of performance trends

Provide subject matter expertise for area of responsibility

Own quality records (change control, CAPA, deviations) and deliver to timelines

Identify and autonomously implement continuous improvement opportunities

Creation of solid business cases for improvement ideas

Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements

Support of front-line managers through on the floor presence

Own and author critical standard operating procedures and supporting documentation/training.

Review and approval of master batch records

Lead and/or support root cause investigations related to performance trends and formal deviations

Support of new product introductions and product reintroductions

Develop, implement and assess solutions for complex problems

Anticipate risk and builds contingencies to help mitigate impact

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Manufacturing and/or Operations experience 

OR

Bachelor’s degree and 5 years of Manufacturing and/or Operations experience 

OR

Associate’s degree and 10 years of Manufacturing and/or Operations experience

OR

High school diploma / GED and 12 years of Manufacturing and/or Operations experience

Preferred Qualifications:

Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment

Strong project management skills with ability to multi-task and function in a dynamic environment

Excellent communication skills, drive, and sense of urgency

Demonstrated ability to forge and maintain strong relationships within other functional areas

Ability to recommend, judge, and make good decisions in complex situations Ability to tactfully and effectively negotiate and influence

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 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.

#OPERATION21

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.