Associate Scientist

Associate Scientist

This position is a support role within the Analytical Method Sciences pillar within the Biologics Analytical Methods & Strategy group.

This position is responsible for providing Analytical Method Configuration support primarily in the troubleshooting, creation, and maintenance for Empower Chromatography Data system master data.

The Role:

• Provide end user support by troubleshooting Empower related queries/questions or re-directing to responsible group when needed
• Create and maintain Empower by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
• Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.
• Communicate impact of lab system changes to integrated systems areas (i.e. trending system, MES, etc).
• Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.
• Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e. visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab metrics.
• Author, revise, and/or review procedural documents, such as SOPs and Wis and contribute to the development of associated training content
• Communicate technical issues and activity status updates to team members/direct management.
• Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.

Qualifications

• Bachelor's degree in relevant scientific, computer, or engineering program with at least 1-3 years' experience in the biopharmaceutical industry, or equivalent combination of education and experience.
• Basic knowledge and understanding of analytical techniques including separations, compendial based assays, and/or bioanalytical based methods.
• Basic knowledge of databases and/or Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs, preferred.
• Ability to understand and follow cGMPs, regulatory requirements, and industry best practices.
• Interpersonal, oral, and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Ability to Provide ad hoc support to users for issues/questions on Empower.
• Ability to work independently and as part of a team.
• Must be flexible to adjust workload to adapt to changing business needs.