Manufacturing Scientist – API Manufacturing Process Support

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:

The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances.  The API EM Manufacturing 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 manufacturing 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 technical services and manufacturing sciences laboratory. 

Responsibilities:

• 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 (Process Flow Documents), 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.

Basic Requirements:

• Bachelors in STEM Discipline (Chemistry focus preferred) and at least 3 years of experience in cGMP manufacturing.

or

• Master's Degree and 1 year experience in cGMP manufacturing.

Additional Preferences:

• Relevant industrial experience in any of the following discipline such as API Manufacturing, TS/MS (Technical Services/ Manufacturing Sciences), 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.

Additional Information:

• Tasks require entering manufacturing areas which require wearing appropriate PPE.
• Domestic and international Travel (variable, can approach 20%).

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