Senior Associate Manufacturing

Job Summary

This Sr. Associate Scheduler position is within Amgen Thousand Oaks Drug Substance Supply (Manufacturing) organization and is responsible for managing the day-to-day production schedule for Purification. This is a highly visible role across the site with the core responsibility of supporting manufacturing and EF&R by delivering a detailed schedule of manufacturing, maintenance, and client activities. This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy. Additionally, this role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations within the global network.

Job scope and responsibilities:

• Build and maintain the Purification production schedule for Clinical and Commercial manufacturing in a multi-suite facility.
• Lead meetings as necessary and update and communicate the schedule to clients.
• Forecast potential issues and help drive solutions.
• Schedule EF&R activities, validation, and project support.
• Work with the various teams (EBR, PTS, PD, CPE, Supply Chain, and Purification) on New Product Introduction and Resupply.
• Requires scientific and technical understanding.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
• May support Manufacturing in troubleshooting Nonconformance events, conducting problem solving and RCAs, owning class 2/3 NCs, and works with Quality, EF&R, EH&S, PD, CPE, etc to develop and own CAPAs to prevent recurrence.
• May collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
• Technical expert who leads or participates in projects to introduce new products and/or advanced technologies into the plant.
• Off business hour on-call support as needed.
• Knowledge of complex excel formulas or background in programming
• General Knowledge of Smartsheets
• Experience with Data Visualizations, generating reports using power BI, Tableau, Spotfire or similar programs

Basic Qualifications:

Master's degree in Chemical Engineering, Industrial Engineering or Life Sciences

OR

Bachelor's degree in Chemical Engineering, Industrial Engineering or Life Sciences and 2 years of manufacturing and operations experience

OR

Associate's degree in Chemical Engineering, Industrial Engineering or Life Sciences and 6 years of manufacturing and operations experience

OR

High school diploma / GED and 8 years of manufacturing and operations experience

Preferred Qualifications:

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences and the following :

• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.

• Technical knowledge of drug substance (upstream and/or downstream) processing and broad understanding of related disciplinary areas

• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling

• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Ability to coach, mentor and/or cross train colleagues within core technical areas

• Background in lean manufacturing methodologies and operational excellence

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.