Lilly Scientist-TS/MS-API EM in Indianapolis, Indiana
The primary focus of API-EM TS/MS-small molecule scientist is to execute laboratory projects (experimental, investigational, and lab modeling) to improve and optimize process control, yield, purity, and/or productivity supporting APIEM technical agenda initiatives. The TS/MS – small molecule scientist should be technically independent in setting up and executing a variety of reactions at laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS small molecule laboratory. Furthermore, the scientist should work in partnership with large molecule laboratory contributing to the site technical agenda initiatives (when needed). The secondary focus of the scientist will be to provide technical support required to achieve the reliable and compliant manufacture of the API External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances.
Ability to independently set up and execute various chemical reactions.
Apply technical expertise to scientific problem solving to support TSMS
Ensure that experiments are well designed with clear objectives
Ability to analyze data and ensure appropriate documentation
Utilize save laboratory practice and adhere to CHP requirements
Write technical reports and documents
Ability to work in a team environment and contribute to either small or large molecule technical projects in the laboratory
Understand the scientific principles required for manufacturing intermediates and bulk drug substances, including the interaction of the chemistry and equipment.
Execute technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity, and/or productivity.
Provide technical support for preparation of relevant technical documents, as required, such as: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
Develop and monitor established metrics in real-time to assess process variability and capability.
Understand, justify and document the state of validation (process and cleaning) with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Ensure that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps.
Provide support to the global and local PLOT teams.
Provide support to internal and joint process teams.
Demonstrated basic knowledge in chemical synthetic in a laboratory settings. Relevant industrial experience in API Manufacturing, small molecule development, or discoveries
Strong problem solving skills,
Excellent analytical, written and oral communication skills.
Familiarity with cGMP manufacturing environment and terminology.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.
No certifications required.
Tasks require working in a laboratory or entering manufacturing areas which require wearing appropriate PPE.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Scientist-Technical Services/Manufacturing Sciences-API EM
Bachelor's degree in scientific disciplines of Organic Chemistry, Biochemistry, Physical Chemistry, or Analytical Chemistry
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
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 39,000 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.
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