Sr. Scientist Peptides Api Em

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 employees 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 put people first and strive to make life better for people around the world.
Company Overview
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its worldwide laboratories and collaborations with eminent scientific organizations.
Headquartered in Indianapolis, Indiana, Lilly aims to improve health through medicines and information for some of the world's most urgent medical needs.
Founded over 145 years ago, Lilly values excellence, integrity, and respect for people, and is frequently ranked as a top company to work for.
Lilly's success comes from its employees—people with innovation, generosity, strong values, and determination to prevail in the face of challenges.
Join our team and make a difference in improving health for people around the world
Organization Overview
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM).
The API EM TS/MS Sr.
Scientist provides technical and scientific expertise within a dynamic external manufacturing environment.
The Sr.
Scientist delivers technical support to achieve reliable and compliant manufacture of API drug substance at external contract manufacturing groups to predetermined global quality standards.
This role interacts daily with a wide variety of people, primarily external partner team members and site management.
The candidate is responsible for process monitoring, response to issues, and improvements where necessary.
A strong understanding of manufacturing principles and Lilly systems is required to ensure those standards are applied to the external contract manufacturers.
The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and corporate/industry standards.
The role requires cross-functional collaboration within the site and with other functions to deliver technical objectives.
Key Objectives/Deliverables
Provide technical oversight and stewardship for peptide manufacturing processes.
Lead resolution of technical issues, including those related to control strategy and manufacturing.
Employ excellent communication skills to manage internal and external relationships.
Build and maintain relationships with development and central technical organizations.
Ensure proper characterization of processes and products and ensure effective documentation of the process description, measures, acceptable ranges, specifications, and the justification of these measures and specifications.
Ensure processes are compliant, capable, in control, and maintained in a validated or qualified state.
Understand, justify and document the state of validation with data that evaluate the capability of the manufacturing process to meet its stated purpose.
Influence and implement the network technical agenda and drive continuous improvement.
Maintain peptide processes in a state of compliance with US and global regulations.
Understand the scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment.
Operate with "Team Lilly" in mind, including coaching and mentoring of peers and other scientists.
Basic Requirements
Bachelor's in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry/Biochemistry strongly preferred)
3+ years of demonstrated experience and proficiency with pharmaceutical manufacturing and working knowledge of regulatory expectations.
Additional Preferences
Knowledge and experience with regulatory requirements
Knowledge of data management practices across manufacturing
Enthusiasm for changes, team spirit and flexibility
Ability to influence and communicate to diverse groups on business or technical issues within the site and function
Proficiency in delivering complex tasks and/or cross-functional tasks
Demonstrated project management and ability to coordinate complex projects
Additional Information
Some travel (