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 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.Description:The Technical Services and Manufacturing Sciences (TS/MS) Representative is a technical position that supports, develops and implements a technical agenda for their area of responsibility. The TS/MS Representative is responsible for providing technical leadership for activities within Indianapolis Device Assembly & Packaging (IDAP), including new product commercialization and commercial product support. Primary objectives include reliable and compliant manufacturing of products, continuous improvement of processes, and supporting day-to-day operations of process teams.Key Objectives/Deliverables:
Own the overall technical agenda for the IDAP site.
Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.
Lead technical projects to improve process control and/or productivity.
Drive technical consistency across process teams.
Serve as interface with development, upstream suppliers, and global device / drug product networks.
Own batch records and revisions, ensuring they are current and accurate.
Facilitate equipment commissioning and qualification activities, as required
Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP
Communicate effectively with process team members, development colleagues, tech transfer team members, and other customers
Understand the scientific principles required for Device Assembly and Packaging operations
Support regulatory submissions as needed
Monitor process control and capability.
Provide off hours support as needed to process team
Minimum Requirements:
Bachelor’s degree or equivalent in a STEM discipline
Technical / Scientific knowledge
Oral and written communication skills that demonstrate effective communication with all levels of an organization
Clear understanding of cGMPs
Good teamwork and interpersonal skills
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Additional Preferences:
Experience in pharmaceutical manufacturing
Cleaning Validation experience
Root Cause Investigation experience
Knowledge of manufacturing statistics
Demonstrated successful leadership of cross-functional teams
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLilly
