Career Category

Job Description

Job Posting Title                Process Development Scientist - 12 month Fixed Term Contract

Career Category                Process Development

Location (City)   Ireland - ADL

Amgen Job Description: The Process Development Scientist provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as being part of the global Process Development organization. The input provided will focus on providing data analytics support to manufacturing through the implementation of process improvement strategies:

• Acts as an SME in Data Analytics for Drug Product Manufacturing, a technical expert who will advance data analytics at the site and provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection, for parenteral products.

• Support of Process Monitoring for all Drug Products manufactured including Deviation/CAPA investigation support. Adopts a customer-centric interface with manufacturing, and all partner support functions, providing robust and coordinated support.

• Champions the use of data-driven analyses and visualizations. Investigates to determine true root cause.

• Identifies and implements operational opportunities for current and new sterile operations.

• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Be a link to manufacturing on key investigations as a Data analytics expert.

Basic Qualifications        

• Bachelor’s degree & 10 years of directly related experience

OR

• Master’s degree & 6 years of directly related experience

• Associate degree & 15 years of directly related experience

Preferred Qualifications

•  master’s in science or Data Analytics

• Strong knowledge of Amgen’s data analytics tools and platforms including Operations Enterprise Data Lake, Dynamic Mapping Engine (DME) & visualisation tools including Spotfire & Tableau
• Knowledge of manufacturing real time monitoring & analysis applications (SIMCA/ Seeq) is an advantage.

• Project management skills including the ability to manage multiple projects and evaluate project resource requirements.

• Strong knowledge of Quality systems, Drug Product Manufacturing and Report Validation.

• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skill are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.