Join American pharmaceutical leader Eli Lilly and Company, currently hiring Sr. Principal Manufacturing Scientist – TS/MS in Indianapolis, Apply Lilly careers in Indianapolis Indiana.
Position : Sr. Principal Manufacturing Scientist – TS/MS
Location : Indianapolis, Indiana
Job id: R-31073
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: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 TS/MS Drug Product Steward (e.g. Sr Principal Manufacturing Scientist) is a key member in a cross-functional team who provides technical leadership the parenteral organization.The TS/MS Drug Product Steward is responsible for providing technical leadership to commercialization activities within Indianapolis Parenteral Manufacturing. The scope of the role includes validation and commercialization of Monoclonal Antibodies/Biologics and Peptide drug product on a new syringe platform. This role is expected to be the technical expert on all products and platforms, and a subject matter expert in commercialization, regulatory, parenteral control strategy, and other requirements. A key part of this role is ensuring that there is consistency in approach/processes, up through and including submission. Lastly, this role is expected to serve as a role model/mentor to other technical employees within the organization.Key Objectives/Deliverables:Serves as technical subject matter expert for validation and commercialization of new parenteral drug product assets, including facility, for Indianapolis Parenteral ManufacturingIdentify opportunities for best practices, and implement improvements to technical transfer business processesDrive technical consistency in technical transfer and validation deliverablesPrepare, review and approve, as required, relevant technical documents such as change controls, regulatory submissions, technical transfer plans, strategy documents, deviations, expert opinions, etc.Serve as technical interface with other manufacturing sites at LillyProvide technical guidance to technical team, as neededAttend management reviews and governance forumsProvide technical and project management oversight to post-launch optimization teams and for technical agenda projectsServe as a technical mentor for scientists, managers, and other disciplinesMinimum Requirements:BS in chemistry, biochemistry, biology, pharmacy, engineering, or other related scientific disciplineAdditional Preferences:10 years of experience of pharmaceutical manufacturing experience, with a preference for parenteral drug product experience.Demonstrated successful leadership of cross-functional teamsDemonstrated success in technical transfer and validation of drug productsOverall deep technical knowledge of parenteral products and control strategiesStrong interpersonal and teamwork skillsStrong self-management and organizational skillsProficiency in delivering highly complex tasks and/or tasks that are highly cross-functionalDemonstrated Project Management skills and ability to coordinate complex projectsOral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organizationThis position is tech ladder approved (P4-R+).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.
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).
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