TS/MS Manufacturing Science Process Flow Mentor

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. Organization Overview:For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always. 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 Flow Mentor is a key member in a cross-functional team who serves as technical subject matter expert for a parenteral drug product manufacturing process and provides technical leadership for other technical staff to achieve the reliable and compliant manufacture of parenteral drug product to predetermined global quality standards. supporting the Indianapolis Parenteral Manufacturing site. Responsibilities:

• Understand the scientific principles required for manufacturing parenteral drug product, including the interaction of the chemistry, sterility assurance and equipment.
• Coach and mentor other scientists in area related to the manufacturing process, operational excellence, technical documentation, issue resolution, and process monitoring to assess process variability and capability
• Work within cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Provide regular communication with Frontline TS/MS staff and Process Teams.
• Interface with the greater scientific community (e.g. Parenteral Network, Commercialization, Research & Development, Bulk API Network) to benchmark practices, network with external partners, and provide technical oversight
• Be responsible and influential with respect to implementation of regulatory guidance, technology advancements, broader external trends and understanding of how changes could impact Eli Lilly
• Author, review, or approve technical documents, including personnel qualification strategies for technical staff, control strategies, investigations, change controls, expert opinions, qualifications, procedures, technical studies, etc.
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Interact with process teams to identify improvement and productivity objectives and drive the technical agenda within area of responsibility. Participate in development and implementation of process improvement, including capital expansions and technical projects.Basic Requirements:
  • Minimum of Bachelor's required in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, or EngineeringAdditional Preferences:
    • Preferred 10 years experience directly supporting pharmaceutical manufacturing or quality, with experience in parenteral pharmaceutical products.
    • Although not a supervisory role, technical leadership capabilities, and the ability to train/coach others.
    • Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function
    • Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
    • Responsible for maintaining a safe work environment. Tasks require entering manufacturing areas which require wearing appropriate PPE.
    • Experience in statistics
    • Builds relationships with internal and external customers and partners
    • Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
    • Strong analytical and quantitative problem solving skills
    • Strategic thinking and ability to balance short term needs with long term business evolutionAdditional Information:
      • This position will be in Indianapolis, but could require some travel, less than 10%; including international
      • This position is day shift, Monday-Friday, with off hours support needed, by request.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 , TS/MS Manufacturing Science Process Flow Mentor, Other , Fairland, Indiana