Associate Scientist, Process Development (Process Validation & Business Strategy)

Role Summary

Associate Scientist, Process Development (Process Validation & Business Strategy) at Amgen. Part of the Process Development Drug Substance Technology group (PD DST) within the Process Validation & Business Strategy team, this role operates across all aspects of a commercial bulk drug substance facility, including process development operation support, developing digital tools to support business processes, and supporting the commercial development of Amgen’s pipeline.

Responsibilities

• Lead and develop the Process Development safety, training, and compliance monitoring operation
• Holistic Lab Execution Environment (HLEE) champion for the process development lab
• Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation
• Develop digital tools to support process validation and process monitoring activities
• Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process
• Provide process floor or lab support as required

Qualifications

• Basic Qualifications:
• Bachelor’s degree and 3 years of Process Development or Scientific experience OR
• Master’s degree and 1 year of Process Development or Scientific experience

• Preferred Qualifications:
• 2 – 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role
• Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes
• Familiarity in operational aspects of process development lab or commercial biopharma manufacturing
• Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks
• Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements
• Excellent written and verbal communication
• Be a self-starter with the ability to take on several projects at one time