Sr. Associate – TS/MS Principal – TS/MS Sr. Principal – TS/MS Advisor – TS/MS

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.

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 Indianapolis Device Assembly and Packaging (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. 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 TS/MS team and other functions within IDAP.

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
• 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 TS/MS, 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
• Clear understanding of cGMPs
• Demonstrated successful leadership/mentorship of cross-functional teams

Additional Preferences:

• Experience in multiple functions within a manufacturing site (operations, engineering, quality, etc.)
• Previous experience in TS/MS or technical function within manufacturing organization
• Pharmaceutical manufacturing experience
• Root Cause Investigation Experience
• Demonstrated technical writing skills
• Good written and oral communications
• Good teamwork and interpersonal skills
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Other Information:

• Some travel <10% (domestic and international) may be required.

This job specification is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

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