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

Eli Lilly and Company • Indianapolis, IN

1d

About The Position

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.

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

Nice To Haves

• 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

Responsibilities

• 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
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees