IDAP TS/MS Steward

Eli Lilly and Company • Indianapolis, IN

4d • $66,000 - $171,600

About The Position

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 Technical Services Manufacturing Scientist (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

• Bachelors degree or higher in engineering, science, or related field
• 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
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Nice To Haves

• 5 years of experience in a manufacturing organization
• 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 successful leadership/mentorship of cross-functional teams
• Demonstrated technical writing 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 capabilities
• 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

Benefits

• employee bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• time off and leave of absence benefits
• 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