Lilly Lead Scientist- Technical Services Manufacturing Science 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 TS/MS Drug Product Steward 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.
Serves as technical subject matter expert for validation and commercialization of new parenteral drug product assets, including facility, for Indianapolis Parenteral Manufacturing
Identify opportunities for best practices, and implement improvements to technical transfer business processes
Drive technical consistency in technical transfer and validation deliverables
Prepare, 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 Lilly
Provide technical guidance to technical team, as needed
Attend management reviews and governance forums
Provide technical and project management oversight to post-launch optimization teams and for technical agenda projects
Serve as a technical mentor for scientists, managers, and other disciplines
- BS in chemistry, biochemistry, biology, pharmacy, engineering, or other related scientific discipline
10 years of experience in more than one function or manufacturing site.
Demonstrated successful leadership of cross-functional teams
Demonstrated success in technical transfer and validation of drug products
Overall deep technical knowledge of parenteral products and control strategies
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
Demonstrated Project Management skills and ability to coordinate complex projects
Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
This position is tech ladder approved (P4-R+).
This position is day shift, Monday-Friday, with off hours support needed, by request.
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. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
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!