Associate - Labeling - US Printed Packaging Development

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.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Printed Packaging Development (PPD) Team assures patients worldwide of safe and efficacious drug product labeling, through development of artwork to support product submissions and production packaging on time and according to regulatory and technical requirements.

The Associate - Labeling is responsible for providing daily support, and artwork project management for packaging - Indianapolis Device Assembly and Packaging (IDAP), Concord, Lilly Research Triangle Park (RTP) and Drug Product External Manufacturing (DPEM). The Associate - Labeling works as a team member supporting multiple labeling functions to achieve timelines while providing BLUE project oversight and guidance.

Responsibilities:

• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
• Responsible for the management of BLUE projects, change controls and specifications following established cGMP processes and applicable procedures.
• Represent PPD department on product launch teams, product planning teams, supply chain/customer service, third parties, regulatory teams and global manufacturing teams.
• Work with various partners including regulatory, quality, marketing and packaging to ensure printed materials are produced in compliance with cGMP standards and meet all customer requirements.
• Coordinate communications with regulatory, quality, marketing, graphics, printer, and packaging to compile critical data (i.e., Regulatory Truth Copy, Branding / Country Specific Requirements and Technical Specifications), make key technical assessments and provide guidance ensuring printed materials are produced in compliance with cGMP.
• Effectively apply project management skills and available resources to prioritize and schedule work, ensuring all due dates and commitments are met.
• Communicate status of artwork creation / revision with management, project teams, print vendors, graphics and PPD team members.
• Collaborate with graphics and print suppliers to ensure the highest quality of artwork electronic files, and ensure materials are delivered on time and according to specifications.
• Provide technical coaching for labeling to packaging engineering, supply chain, regulatory, marketing and quality personnel to increase printed packaging development knowledge and to drive improved outcomes.

Basic Requirements:

• Bachelor’s Degree required

• 3-5 years’ experience in MP, packaging, project management, SAP, Supply Chain

• 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.

Additional Preferences:

• Demonstrated experience in a GMP facility preferred
• Prior experience in pharmaceutical operations, packaging, cGMP quality control, printing, regulatory, or marketing.
• Demonstrated strong interpersonal skills and the ability to work as a team, or independently
• Ability to learn quickly, multi-task, and apply new skills.
• Computer skills (MS word, MS Excel, Adobe Acrobat, etc.)
• Solid project management, organization, and scheduling skills
• Strong technical skills related to packaging and / or printing
• Knowledge of Adobe Software
• Strong oral and written communication and interpersonal skills
• Ability to work with constant changes, time pressure, interruptions, and distractions
• Knowledge and application of operation systems: BLUE, SAP, Veeva, and TrackWise

Other Information:

• Position is day shift Monday through Friday, but second shift work may be required.
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