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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Position Brand Description:

The TS/MS Product Steward is a position that supports, develops, and implements a technical agenda, and is responsible for providing technical leadership across all processes and products within the IDAP site. Primary objectives include maintaining the validated state of all IDAP processes, establishing metrics to ensure a state of capability and control, harmonization of control strategies across process teams, improvement of the processes, and serving as an escalation point for day-to-day operations issues . The role is also responsible for technical leadership of commercialization activities at the site. This role is expected to serve as a mentor to other employees within the IDAP TS/MS team.

Key Objectives/Deliverables:

Own Tech Transfer and Validation strategy for the manufacturing site

Participate in equipment/product/format commissioning, qualification, and validation activities

Represent TS/MS team to the IDAP Site Lead team

Mentor TS/MS process team members

Provide technical support to non-routine (e.g., deviation, complaint) investigations

Prepare, review, and approve, as required, relevant technical documents such as: annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.

Monitor process control and capability

Lead technical projects to improve process control and/or productivity

Drive technical consistency across process teams

Serve as interface with upstream suppliers and global device/drug product networks

Serve as a technical mentor for engineers, managers, and other disciplines

Collaborate with Commercialization Project Manager as well as cross-functional tech transfer team members to commercialize new products in IDAP

Minimum Requirements:

Bachelor's degree or higher in engineering, science, or related field

5 years of experience in a manufacturing organization

Good written and oral communications

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 multiple functions within a manufacturing site (operations, engineering, quality, etc.)

Previous experience in TS/MS

Pharmaceutical manufacturing experience

Root Cause Investigation Experience

Demonstrated successful leadership of cross-functional teams

Demonstrated technical writing skills

Other Information:

Some travel (domestic and international) may be required.

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.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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