Scientist - TS/MS Manufacturing - Visual Inspection

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.

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 Visual Inspection Scientist provide technical support to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards via a detailed set of manufacturing instructions and procedures.  This person interacts daily with a wide variety of people, including customers, other personnel and site management.

Key Objectives / Deliverables:

• 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 positive fashion to implement technical objectives and deliver on business plan, quality objectives or to improve process control, yield, and/or productivity.

Minimum Requirements:

Bachelors in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, Engineering or related scientific field

Additional Preferences:

• Preferred 3 years experience directly supporting pharmaceutical manufacturing or quality, with experience in visual inspection of pharmaceutical products.
• 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

Other Information:

• 8-hour days –Monday through Friday
• Off hours support may be needed, by request
• Required to respond, off shift, to operational issues
• Minimal travel required
• Applicant will work in various areas within the Parenteral Plant.  Some allergens are present in the parenteral plant.  Mobility requirements and exposure to allergens should be considered when applying for this position.

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. 

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