Technical Services/Manufacturing Science Scientist (API EM)
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 35,000 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.
The API EM TS/MS Scientist provides the 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. 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
· PhD in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry with a minimum of 3-5 years of industry experience.
· 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
· 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.
· No certifications required.
· Tasks require entering manufacturing areas which require wearing appropriate PPE.
· Domestic and international Travel (variable, can approach 20%)
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly 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.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-31174.
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.
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