Process Scientist - TS​/MS Lab - Lebanon API Manufacturing

Process Scientist - TS/MS Lab - Lebanon API Manufacturing

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

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

Lilly is seeking a process chemist to join its Lebanon API TS/MS (Technical Services/Manufacturing Science) team. This position is responsible for designing and executing lab experimentation aimed to transfer processes, characterize processes, troubleshoot process upsets, and provide recommendations for process improvements.

The TS/MS Process Scientist is part of the Lilly Lebanon API TS/MS laboratory team. This position will be small molecule focused and will require interaction with Quality Assurance, Quality Control, Procurement, Warehouse, Regulatory departments, and other Lilly sites. Knowledge of chemistry and understand the scientific principles required for the manufacturing and testing of intermediates and bulk drug substances is required. Knowledge of organic synthesis and experience in API manufacturing are a plus.

Knowledge of peptide synthesis is a plus.

• Complete laboratory experimentation aimed at achieving the successful process development and transfer
• Developing experimental studies to address process upsets in routine manufacturing
• Design and perform range finding studies to enable effective process characterization
• Identify potential for process optimization to improve yield and throughput
• Coordinate with TS/MS team to setup models to support manufacturing as required
• Accurately record data in accordance with TS/MS laboratory procedures
• Adhere to all Environmental, Health, and Safety standards
• Effective management of multiple projects
• Utilizes technical skills to lead or perform in‑depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent recurrence
• Communicate effectively in both written and oral formats
• Participate in internal/external audits as needed

• Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmaceutical Science). Advanced degree (MS or PhD) preferred but not required
• 1+ year of laboratory experience in a cGMP environment

• Excellent communication skills, both oral and written
• Ability to independently master assigned processes and to coordinate activities with internal and external partners
• Advanced degree in Organic Chemistry
• Experience with small molecule pharmaceutical development and characterization
• Experience in API manufacturing
• An understanding of cGMP and regulatory requirements
• Experience with continuous processing is a plus
• Experience with process characterization is a plus
• Experience transferring processes into GMP manufacturing is a plus
• Experience with chemical process safety/calorimetry is a plus

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