Scientist Process Analytical Technologies Lilly Medicine Foundry

Responsibilities

• Drive implementation of technical solutions and analytical strategies via PAT to enable drug substance production at the Lilly Medicine Foundry.
• Investigate the feasibility of instruments to use for in-line monitoring.
• Ensure methods are technically sound, well developed, and fit-for-purpose.
• Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, PAT, and modeling and simulation).
• Support automation development (i.e., integrated control systems) between PAT tools and process data systems (i.e., synTQ or other systems).
• Plan and manage short-term and long-term development activities.
• Develop and/or review technical agendas and timelines for project work.
• Recommend resource allocation to accomplish projects according to plans, communicate progress and propose changes in timeline, objectives, or direction.
• Collaborate closely with organizations across development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
• Welcome varied perspectives to create new solutions.
• Cookordination instrumentations between different projects to allow equal usage of available tools for project specific needs.
• Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
• Ensure work and team activities are aligned with all relevant development quality, regulatory, HSE, GLP and GMP requirements.

Requirements

• B.S. in chemistry, chemical engineering, or related field.
• Experience with using analytical equipment in regulated industrial environment.
• Experience with product development, including technical transfer of analytical methods into manufacturing operations.
• Demonstrated ability to drive and accept change.
• Good interpersonal skills and a sustained tendency for collaboration.
• Demonstrated success in persuasion, influence, and negotiation.
• Able to prioritize multiple activities and manage ambiguity.
• Strong communication (oral, written), organizational, and leadership skills.

Basic Requirements

• Qualified candidates must be legally authorized to be employed in the United States.

Additional Preferences

• Experience with product development, including technical transfer of analytical methods into manufacturing operations.
• Demonstrated ability to drive and accept change.
• Good interpersonal skills and a sustained tendency for collaboration.
• Demonstrated success in persuasion, influence, and negotiation.
• Able to prioritize multiple activities and manage ambiguity.
• Strong communication (oral, written), organizational, and leadership skills.