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Principal Scientist - Visual Inspection, Indianapolis Parenteral Manufacturing

Company: Eli Lilly
Location: Carmel
Posted on: September 20, 2022

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 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 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.

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 positive fashion to implement technical objectives and deliver on business plan, quality objectives or to improve process control, yield, and/or productivity.Basic Qualifications:
    • Bachelors in scientific disciplines of Biochemistry, Chemistry, Microbiology, Pharmacy, or Engineering are minimum requirements.Additional Information:
      • 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
      • 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.

        Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

        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.

        Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

        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 (subject to applicable law).

        #WeAreLilly

        Required
        Preferred
        Job Industries
        • Warehouse & Production

Keywords: Eli Lilly, Carmel , Principal Scientist - Visual Inspection, Indianapolis Parenteral Manufacturing, Other , Carmel, Indiana

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