Advisor Process Analytical Technologies for Biologics Lilly Medicine Foundry
Eli Lilly and Company
5 months ago
On-site
Lebanon, IN
Operations
Responsibilities:
- Drive implementation of technical solutions and analytical strategies via PAT to enable biologic drug substance production.
- Provide technical leadership for adopting and using PAT (e.g., Raman, UV, capacitance) in upstream and downstream biological processes; investigate instrument feasibility for in-line monitoring; ensure methods are technically sound and fit-for-purpose.
- Demonstrate learning agility across biochemistry, PAT, and modeling/simulation.
- Support automation development integrating PAT tools with process data systems (e.g., synTQ or others).
- Mentor and develop scientific staff; encourage excellence and knowledge sharing.
- Plan and manage short- and long-term development activities; develop/review technical agendas and timelines; recommend resource allocation; communicate progress and propose changes.
- Collaborate with development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
- Welcome varied perspectives to create new solutions.
- Coordinate instrumentation between projects for equitable tool usage.
- Author or contribute to technical documents (SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, scientific papers).
- Ensure alignment with development quality, regulatory, HSE, GLP, and GMP requirements.
Basic Requirements:
- Ph.D. in biochemistry, chemical engineering, biochemical engineering or related STEM; or M.S. with 10+ years. Background in process analytics focused on bioprocess analytics (spectroscopy, chromatography, and/or cell culture monitoring).
- Demonstrated expertise leading analytical efforts in pharmaceutical product development/commercialization; proven method development/validation/transfer.
- Fundamental cGMP compliance knowledge and cGMP experience.
Additional Preferences:
- Product development experience, including technical transfer of analytical methods to manufacturing.
- Ability to drive and accept change; strong collaboration.
- Persuasion/influence/negotiation skills; ability to prioritize multiple activities and manage ambiguity.
- Strong communication (oral/written), organizational, and leadership skills.
Other Information:
- Initial location: Lilly Technology Center or Parkwood West (Indianapolis). Permanent location: Lilly Medicine Foundry (Lebanon, IN). On-site required; 8-hour days, 5 days/week; 0–10% travel.
- Drive implementation of technical solutions and analytical strategies via PAT to enable biologic drug substance production.
- Provide technical leadership for adopting and using PAT (e.g., Raman, UV, capacitance) in upstream and downstream biological processes; investigate instrument feasibility for in-line monitoring; ensure methods are technically sound and fit-for-purpose.
- Demonstrate learning agility across biochemistry, PAT, and modeling/simulation.
- Support automation development integrating PAT tools with process data systems (e.g., synTQ or others).
- Mentor and develop scientific staff; encourage excellence and knowledge sharing.
- Plan and manage short- and long-term development activities; develop/review technical agendas and timelines; recommend resource allocation; communicate progress and propose changes.
- Collaborate with development and manufacturing to deliver material and information for clinical trials and regulatory submissions.
- Welcome varied perspectives to create new solutions.
- Coordinate instrumentation between projects for equitable tool usage.
- Author or contribute to technical documents (SOPs, technology transfer documents, process flow diagrams, regulatory submissions, patents, scientific papers).
- Ensure alignment with development quality, regulatory, HSE, GLP, and GMP requirements.
Basic Requirements:
- Ph.D. in biochemistry, chemical engineering, biochemical engineering or related STEM; or M.S. with 10+ years. Background in process analytics focused on bioprocess analytics (spectroscopy, chromatography, and/or cell culture monitoring).
- Demonstrated expertise leading analytical efforts in pharmaceutical product development/commercialization; proven method development/validation/transfer.
- Fundamental cGMP compliance knowledge and cGMP experience.
Additional Preferences:
- Product development experience, including technical transfer of analytical methods to manufacturing.
- Ability to drive and accept change; strong collaboration.
- Persuasion/influence/negotiation skills; ability to prioritize multiple activities and manage ambiguity.
- Strong communication (oral/written), organizational, and leadership skills.
Other Information:
- Initial location: Lilly Technology Center or Parkwood West (Indianapolis). Permanent location: Lilly Medicine Foundry (Lebanon, IN). On-site required; 8-hour days, 5 days/week; 0–10% travel.