Scientist Primary Loop Technical Service / Manufacturing Sciences (Night Shift)

Company: Eli Lilly
Location: Fairland
Posted on: August 7, 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 Primary Loop Scientist provides frontline, technical support to to the manufacturing operations through either product- and process- focused ownership to achieve the reliable and compliant manufacture of parenteral drug product per a detailed set of manufacturing instructions and procedures. This role interacts daily with a wide variety of people, including cross-functional team members, Operations staff, other personnel, plant leadership and other Lilly sites as needed. This Primary Loop position will provide the technical support as described above during the night shift, in addition to other responsibilities. 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 Documentation describe the process as performed and the control strategy for the discrete manufacturing steps.
• Monitor the technical performance of manufacturing regularly through observation, interactions in production areas, and review of production and quality data to assure the process is in control and capable.
• Provide technical input as part of a cross-functional team when issues arise during manufacturing.
• Provide technical leadership to TS/MS and cross-functional teams including troubleshooting, risk assessments, process ownership and technical agenda/project management
• 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, manufacturing ticket inserts, procedures, PFDs, VMPs, APRs, QPPAs, etc.
• Support or lead projects for improvement to the process, training, procedures, and other controls to assure reliable supply, improve process control, yield, purity, and/or productivity.
• Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
• Understands, and performs all job responsibilities in compliance with safety and regulatory expectations as well as cGMP.
• Engage in internal and external networking with various functional teams to ensure proper knowledge and data transfers.Minimum Requirements:
  • Bachelor's or other 4 year degree in a scientific discipline of Biochemistry, Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Biology, Analytical Chemistry, Chemical Engineering or related Engineering discipline
  • MUST be able to work on night shiftAdditional Preferences:
    • Technical/Scientific knowledge
    • Strong written and oral communication skills
    • Clear understanding of cGMPs within a pharmaceutical manufacturing environment
    • Teamwork, ability to influence teams, and interpersonal skills
    • Computer skills
    • Decision making
    • Multi-tasking
    • Problem solvingAdditional Information:
      • This role is primarily a weekday night shift position, with on-call hours support expected, as needed.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). #WeAreLillyRequired
        Preferred

        Job Industries

        • Warehouse & Production

Keywords: Eli Lilly, Indianapolis , Scientist Primary Loop Technical Service / Manufacturing Sciences (Night Shift), IT / Software / Systems , Fairland, Indiana