Sr. Scientist TS/MS - Parenteral Manufacturing

Eli Lilly and Company; Indianapolis (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Secondary Loop Scientist to provide technical support in the manufacturing of parenteral drug products. This role involves understanding scientific principles, developing metrics for process assessment, and preparing essential technical documents. The ideal candidate will have a strong background in scientific disciplines such as Biochemistry or Chemistry, along with experience in pharmaceutical manufacturing. Join a forward-thinking company dedicated to improving lives through innovative healthcare solutions and be part of a collaborative team focused on quality and compliance.

Qualifications

• 2-3 years of experience in pharmaceutical manufacturing or quality.
• Experience in aseptic manufacturing is preferred.

Responsibilities

• Provide technical support for the manufacture of parenteral drug products.
• Develop and monitor metrics to assess process variability.
• Prepare and review technical documents for manufacturing processes.

Skills

Analytical Skills

Project Management

Communication Skills

Statistical Analysis

Problem-Solving Skills

Education

Bachelor in Biochemistry

Bachelor in Chemistry

Bachelor in Microbiology

Bachelor in Pharmacy

Bachelor in Engineering

Job description

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 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 provides technical support to achieve the reliable and compliant manufacture of parenteral drug products 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 for preparation of relevant technical documents, as required, 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.
• Participate in development and implementation of process improvements, including capital expansions and technical projects. Work within or lead cross-functional teams in a positive fashion to implement technical objectives and deliver on business plans, quality objectives or to improve process control, yield, and/or productivity.

Minimum Requirements:

• Bachelors in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, or Engineering are minimum requirements.
• Must have 2-3 years of experience directly supporting pharmaceutical manufacturing or quality, with experience in aseptic manufacturing preferred.

Additional Information:

• Experience in Visual Inspection of injectable products 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 complex tasks and/or tasks that are cross-functional.
• Demonstrated Project Management skills and ability to coordinate complex projects.
• Strong analytical and quantitative problem-solving skills.
• Strategic 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.