Lilly Scientist-TS/MS in Indianapolis, Indiana
Type of Employment:
Full-Time Employment - FTE
The Active Product Ingredient-External Manufacturing (API-EM) Technical Services/Manufacturing Science (TS/MS) Scientist provides the technical support required to achieve the reliable and compliant manufacture of the API-EM portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM TS/MS Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the TS/MS scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the TS/MS 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 internal and joint process teams and to the global and local PLOT teams.
Ability to independently set up and execute various chemical reactions.
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
Bachelor's Degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
Demonstrated basic knowledge in small or large molecule API Manufacturing
Organic Chemistry background preferred
Familiarity with cGMP manufacturing environment and terminology.
Excellent analytical, interpersonal, written and oral communication skills.
Ability to work independently as well as part of a team.
Ability to prioritize activities.
Good judgment and flexibility.
Complete learning plan for API EM TS/MS Scientist.
Tasks require entering manufacturing areas which require wearing appropriate PPE.
Domestic and international Travel (variable, can approach 20%)
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.
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. #WeAreLilly
Region: North America
Req Id: 54465BR