Printed Packaging Development Technical Lead

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 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 PPD Technical Lead is responsible for providing technical guidance for members of the PPD team, working with the Graphic Agencies for project support, 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 PPD Technical Lead 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.
• Provide technical expertise and coaching to PPD team members, packaging engineering, supply chain, regulatory, marketing and quality personnel to increase printed packaging development knowledge and to drive improved outcomes.
• Work with cross-functional teams to identify both local and global process improvement projects and drive solutions and implementation at the site.
• Lead weekly priority meetings with PPD team members and external Graphic Agencies to ensure the highest quality of artwork electronic files, and ensure materials are delivered on time and according to specifications.
• Represent PPD department on product launch teams, product planning teams, supply chain / customer service, third parties, regulatory, and global manufacturing teams to influence outcomes of complex regulatory, business, or technical issues.
• Responsible for the management of BLUE projects, change controls and specifications following established cGMP processes and applicable procedures.
  • 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 utilize 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.

• Bachelor's Degree in STEM field.

• Strong technical skills related to packaging and / or printing.
• Demonstrated relevant experience in a GMP facility.
• Solid project management, organization, and scheduling skills.
• 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.
• Demonstrated ability to learn quickly, multi-task, and utilize new skills.
• Computer skills (MS word, MS Excel, Adobe Acrobat, etc.).

• Strong oral and written communication.
• Ability to work with constant changes, time pressure, interruptions, and distractions.
• Knowledge and application of operation systems: BLUE, SAP, Veeva, and TrackWise

• Position is first shift Monday through Friday, but off-hours shift work may be required.
• Occasional overtime may be required, planned and unplanned, including weekends.
• Some travel may be required (