Sr. Principal/Advisor Flow Mentor- TSMS

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Organization Overview: 

Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. 

Main Purpose and Objectives:

The TS/MS Flow Mentor, part of the Lilly Lebanon API Technical Service/Manufacturing Science (TS/MS) team, offers expert technical leadership in developing, implementing, and maintaining Peptide strategies and the technical agenda for the Lilly Lebanon API site. This role is essential during start-up, implementation, and ongoing operations. The Flow Mentor spearheads technical projects to ensure reliable and compliant manufacturing of API molecules, overseeing initiatives including experimental studies, modeling, and production data analysis to enhance process control, yield, purity, and productivity. Responsibilities also include refining process control strategies, validation approaches, continual process chemistry optimization, and integrating new manufacturing technologies. Additionally, the Flow Mentor mentors frontline scientists and establishes processes to sustain scientific process knowledge.

During the project's delivery and startup phase, the Flow Mentor role will be adaptive and dynamic. The focus will be on supporting project execution, building a new organizational structure, creating and implementing the necessary systems and business processes for GMP operations, and cultivating the site culture. This will demand significant collaboration, creativity, and resilience as the site evolves into a full-scale GMP manufacturing operation from startup.  

Key Responsibilities: 

• Act as a technical mentor for scientists and other disciplines.
• Provide technical support to non-routine issues, investigations, including consultation on quality and stability issues. 
• Prepare, review, and approve technical documents, including Change Controls, Regulatory Submissions, Deviations, Validations, Batch Production Records, SOPs, Process Flow Documents, etc.
• Coordinate technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity and/or productivity. 
• Prepare Annual Product Reviews.
• Guide the development and implementation of new manufacturing technologies to improve existing commercial manufacturing processes.
• Oversee development and improvement of the operational control strategy.
• Provide project management oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects.
• Coach and mentor frontline Scientists in aspects of fundamental TS/MS support including process understanding (both theoretical and practical), problem solving, and project management.
• Champion the application of statistical thinking and use of data to (a) monitor process performance and make science-based decisions, and (b) understand process variability and capability and drive improvements.
• Own a technical agenda for a molecule or aspects of a molecule, or validation process.

Minimum Requirements: 

• Bachelor’s Degree in STEM Discipline (chemistry preferred) and at least 5 years of experience in cGMP manufacturing OR Master’s Degree and 3 years experience in cGMP manufacturing.
• Relevant experience in a frontline technical role directly supporting intermediate and/or drug substance manufacturing required.

Additional Preferences: 

• Previous experience in disciplines such as Quality Control, Quality Assurance, procurement, advanced project management, development, regulatory, or administration
• Demonstrated advanced knowledge in small molecule, peptide, or oligonucleotide API Manufacturing in a cGMP manufacturing environment.
• Proven ability to work within cross-functional Process Teams.
• Proficient in identifying and implementing improvement opportunities.
• Guidance/mentoring of others through processes.
• Flexibility to meet business needs.

Additional Information:

• Travel up to 15%.
• Occasional on-call support.

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