TSMS Analytical Scientist - Eli Lilly and Company : Job Details

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.

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 Analytical Scientist is part of the Lilly Lebanon API TS/MS team that provides technical and analytical support to the Lebanon TS/MS laboratory. This position will support both small molecule and peptide development and manufacturing, and may require interaction with Quality Assurance, Quality Control, Procurement, Warehouse, Regulatory departments, and other Lilly sites. Knowledge of chemistry and understanding of 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.

Key Responsibilities:

* Utilize technical skills to accurately and safely perform analytical test methods or related support activities as per procedures or protocols in support of the TSMS team.

* Responsible for method transfer and implementation of analytical control strategies to support the TSMS laboratory.

* Responsible for leading and supporting the analytical aspects of a project with the TSMS team and other functional areas.

* Work with TSMS team and involved in impurity identification as necessary.

* Recognizing typical and atypical analytical results and communicate results promptly with the TSMS team.

* Coordinate with TSMS team to setup models to support manufacturing as required.

* Review of analytical test method packages.

* Ensure consistent practices among TSMS team running the same method.

* Accurately record data in accordance with TSMS laboratory procedures, standards, and GMP requirements.

* Adhere to all Environmental, Health, and Safety standards.

* Technical review and interpretation of data, stability, process validation, and reference standard characterization.

* 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 reoccurrence.

* Develop investigation testing protocols and perform testing as required.

* Communicate effectively in both written and oral formats.

* Participate in internal/external audits as needed.

* Maintain inventory of all supplies and consumables associated with the analytical instruments.

* Troubleshoot equipment and methods as required.

* Coordinate both internally and externally to ensure the analytical instruments are properly maintained and qualified.

Minimum Requirements:

* Bachelor's degree in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmaceutical Science). Advanced degree (MS or PhD) preferred but not required.

* 3 + years of pharmaceutical laboratory experience required

Additional Preferences:

* Excellent communication skills, both oral and written.

* Ability to independently master assigned processes and to coordinate activities with internal and external partners.

* Experience with small molecule pharmaceutical development and characterization.

* Experience in API manufacturing.

* An understanding of cGMP and regulatory requirements.

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