Senior Scientist – Manufacturing Science

Senior Scientist – Manufacturing Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Senior Scientist – Manufacturing Science 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 Senior Scientist – Manufacturing Science executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity.

In addition, the Senior Scientist – Manufacturing Science 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.

Key Objectives/Deliverables:

• 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 safe laboratory practice and adhere to CHP requirements.
• Write technical reports and documents.

Basic Requirements:

• Bachelors degree in scientific disciplines of Biochemistry, Organic Chemistry, Chemical Engineering, Physical Chemistry, Bioanalytical Chemistry, Analytical Chemistry.
• 3+ years of relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS, Quality Control, Quality Assurance, or Development.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences:

• Demonstrated basic knowledge in small 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.

Other Information:

• 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%).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you…