Lilly Manufacturing Science Process Mentor in Indianapolis, Indiana
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.
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
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 Manufacturing Science Process Mentor (Flow Mentor) is a key member in a cross-functional team who serves as technical subject matter expert for a biologic parenteral drug product manufacturing process and provides technical leadership for other technical staff to achieve the reliable and compliant manufacture of biologic parenteral drug product to predetermined global quality standards. supporting the Indianapolis Parenteral Manufacturing site.
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.
- Minimum of Bachelor’s required in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, or Engineering
Preferred 10 years experience directly supporting pharmaceutical manufacturing or quality, with experience in parenteral processing and biologics/monoclonal antibodies/large molecules.
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 evolution
This position is tech ladder approved (P4-R+).
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 ( LillyRecruitingCompliance@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.
As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!