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Manufacturing Scientist- Secondary Loop

Indianapolis, Indiana

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Req ID R-14006 Title Manufacturing Scientist- Secondary Loop City Indianapolis State / Province Indiana Country United States

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.

Company Overview:

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

Organization Overview:

The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine today and tomorrow. The Secondary Loop Scientist will provide technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards. The Secondary Loop Scientist provides additional support to the manufacturing operations through either product/project/process focused ownership. This person interacts daily with a wide variety of people, including customers, other personnel and site management.

Responsibilities:

  • Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems on inspection processes.
  • Ensure that an accurate instruction set (tickets & procedures) and process flow document describe the process as performed and the control strategy for the discrete manufacturing steps.
  • Develop, monitor and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
  • Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
  • Prepare, review, approve, and provide technical support/leadership for preparation of relevant technical documents, as the need arises, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, process flow documents, validation master plans, annual product reviews, periodic monitoring, etc.
  • Engage in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross- functional teams in positive fashion to implement technical objectives and deliver on business plan, quality objectives or to improve process control, yield, and/or efficiency.

Minimum Requirements:

Bachelors in scientific fields of Biochemistry, Chemistry, Microbiology, Pharmacy, or Engineering are minimum requirements.

Additional Information:

  • Preferred proven experience directly supporting pharmaceutical manufacturing or quality, with experience in aseptic manufacturing preferred.
  • Ability to influence and communicate to diverse groups on business, or technical issues within the site and function
  • Responsible for maintaining a safe work environment
  • Experience in statistics and stackable tolerance analysis
  • Builds relationships with internal and external customers and partners
  • Proficiency in delivering sophisticated tasks and/or tasks that are cross-functional
  • Proven Project Management skills and ability to coordinate sophisticated projects
  • Strong analytical and quantitative problem solving skills
  • Critical thinking and ability to balance short term needs with long term business evolution
  • This position is day shift, Monday-Friday, with off hours support needed, by request.

This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.


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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company.  If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com. 

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-14006.

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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