Advisor Process Analytical Technologies Lilly Medicine Foundry
Eli Lilly and Company
3 months ago
On-site
Lebanon, IN
$126,000 - $204,600 USD yearly
Operations
Responsibilities:
- Drive implementation of technical solutions and analytical strategies via Process Analytical Technology (PAT) to enable drug substance production at the Lilly Medicine Foundry.
- Provide technical leadership for PAT adoption and execution; investigate feasibility of instruments for in-line monitoring; ensure methods are technically sound, well developed, and fit-for-purpose.
- Demonstrate high learning agility across subject areas (e.g., chemistry, PAT, modeling and simulation).
- Support automation development by integrating PAT tools with process data systems (e.g., synTQ or other systems).
- Mentor and develop scientific staff; encourage knowledge sharing and continued growth.
- Plan and manage short- and long-term development activities, including technical agendas/timelines; recommend resources; communicate progress and propose changes.
- Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions.
- Welcome varied perspectives to create new solutions.
- Coordinate instrumentation across projects to enable equal usage of available tools.
- Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
- Ensure activities align with development quality, regulatory, HSE, GLP, and GMP requirements.
Basic Requirements:
- Ph.D. in chemistry, chemical engineering, or related field; OR B.S./M.S. with 10+ years of experience. Process analytics background with focus on LC/MS and GC/MS preferred.
- Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization; experience developing, validating, and transferring analytical methods.
- Fundamental knowledge of cGMP compliance requirements and cGMP experience.
Additional Preferences:
- Experience with product development and technical transfer of analytical methods into manufacturing operations.
- Ability to drive and accept change.
- Strong interpersonal skills and collaboration mindset.
- Success in persuasion, influence, and negotiation.
- Ability to prioritize multiple activities and manage ambiguity.
- Strong oral/written communication, organizational, and leadership skills.
Other Information (role-related):
- On-site role; 8-hour days, five days per week; flexibility for shutdowns/weekends as needed.
- Initial location: Lilly Technology Center (Indianapolis). Permanent location: Lilly Medicine Foundry (Lebanon, Indiana). Travel: 0–10%.
- Drive implementation of technical solutions and analytical strategies via Process Analytical Technology (PAT) to enable drug substance production at the Lilly Medicine Foundry.
- Provide technical leadership for PAT adoption and execution; investigate feasibility of instruments for in-line monitoring; ensure methods are technically sound, well developed, and fit-for-purpose.
- Demonstrate high learning agility across subject areas (e.g., chemistry, PAT, modeling and simulation).
- Support automation development by integrating PAT tools with process data systems (e.g., synTQ or other systems).
- Mentor and develop scientific staff; encourage knowledge sharing and continued growth.
- Plan and manage short- and long-term development activities, including technical agendas/timelines; recommend resources; communicate progress and propose changes.
- Collaborate with development and manufacturing organizations to deliver material and information for clinical trials and regulatory submissions.
- Welcome varied perspectives to create new solutions.
- Coordinate instrumentation across projects to enable equal usage of available tools.
- Author or contribute to technical documents including SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, and scientific papers.
- Ensure activities align with development quality, regulatory, HSE, GLP, and GMP requirements.
Basic Requirements:
- Ph.D. in chemistry, chemical engineering, or related field; OR B.S./M.S. with 10+ years of experience. Process analytics background with focus on LC/MS and GC/MS preferred.
- Demonstrated expertise leading analytical efforts in pharmaceutical product development and commercialization; experience developing, validating, and transferring analytical methods.
- Fundamental knowledge of cGMP compliance requirements and cGMP experience.
Additional Preferences:
- Experience with product development and technical transfer of analytical methods into manufacturing operations.
- Ability to drive and accept change.
- Strong interpersonal skills and collaboration mindset.
- Success in persuasion, influence, and negotiation.
- Ability to prioritize multiple activities and manage ambiguity.
- Strong oral/written communication, organizational, and leadership skills.
Other Information (role-related):
- On-site role; 8-hour days, five days per week; flexibility for shutdowns/weekends as needed.
- Initial location: Lilly Technology Center (Indianapolis). Permanent location: Lilly Medicine Foundry (Lebanon, Indiana). Travel: 0–10%.