Global Program Manager-Idm

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.

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.

Indianapolis Device Manufacturing (IDM) is responsible for commercialization of new medical devices and combination products. We lead establishing manufacturing capacity and capability in the global Lilly Device Network and our external manufacturing partners.

Responsibilities:

The Global Program Manager (Commercialization Engineer) is the single device manufacturing owner to orchestrate all manufacturing activities to bring a new device to launch and/or knowledge transfer / tech transfer for specified capacity expansion programs.

New Device Programs: The GPM is the "voice" for manufacturing into the Device Development organization. Through personal inputs and by orchestrating other manufacturing SMEs, effectively influence R&D programs so that products & processes are developed to improve manufacturing robustness & minimize capital/cost of product. New Product Introduction(NPI) requires partnership & influence with leaders of the Business Units, Manufacturing Strategy, Device R&D, Regulatory, Lilly manufacturing sites, Contract Manufacturing (CM) firms, and all IDM functions.

New Capacity Programs: The GPM provides overall program integration for device capacity to new CMs and/or new external sites, with a focus on Knowledge Transfer, CM Tech Transfer, and gap assessment coordination. Collaborate with IDM Asset Delivery, External Mfg groups (ex. DPEM or IDM CMO), and CM partners to develop and deliver a plan for manufacturing start-up and scale-up.

• Product Development – Partner with & influence Device R&D to design new products that are manufacturable, Cost of product/capital-optimized and customer delighting

• Be the manufacturing voice on new device development teams to influence device design for maximum manufacturing robustness and minimum COPS/capital

• Identify the greatest manufacturing risks & assure SMEs are engaged and studies are completed to mitigate them

• Drive DFx inputs & manufacturing process development, using IDM, CMO and Lilly site SMEs

• Develop solutions to improve manufacturing outcomes by using IDM,CMO & Lilly site SMEs

• Manufacturing Commercialization – Develop the manufacturing supply chain for new products; run and synchronize multiple subprojects with CMOs, Lilly manufacturing sites to establish that supply chain; then lead tech transfer to actualize it

• Partner with Manufacturing Strategy to define the manufacturing strategy, supply chain, and gain MPC sourcing gate approvals

• With Procurement and IDM Contract Manufacturing Operations, drive the CM selection process

• With IDM Capital Delivery, ensure the development of capital estimates, partner with GFD to satisfy all gates/approvals*

• Lead teams across sites to deliver facilities, molds & automation*

• Partner with Regulatory to establish submission plans that synchronize with manufacturing plans*

• Partner with each receiving site (Lilly, Partner or CMO) to establish robust tech transfer plans*

• Supervise the execution of tech transfer to the CM and/or Lilly sites*

• Assure all GCMS and GQS requirements are met throughout this process*

• Program Planning & Resource Management - platform and commercial portfolio project coordination and prioritization

• Estimate resources needed from all functions to complete these multi-site projects*

• Maintain resource planning model to aggregate resource needs to support management business planning*

• Network with management to assure resources availability for the projects, then maintain communication of project status, changes & personnel performance on the project*

• Track program metrics for schedule, COPS changes, capital budget, resourcing - report to management*

• Communicate program strategy and status to key business leaders/customers*

• Develop strategies in support of Long Range Plan and Business Planning goals*

• Maintain project portfolio to advise IDM management of upcoming product and manufacturing*

• Device Commercialization business process improvement

• Designates objective and deliverable for New Capacity Programs

Basic Qualifications:

• Bachelor Degree required

• 5+ years experience in medical device or combination product development, new product introduction or commercialization and/or operations

Additional Skills/Preferences:

• Demonstrated ability to work in a team environment and influence the strategic and technical direction for sophisticated innovative programs

• Demonstrated ability to engage in device design reviews and technical problem solving discussions

• Strong project management skills with demonstrated success leading multi-company projects and synchronizing multiple subproject plans

• Strong capability to work across boundaries (companies, teams, etc.)

• Experience in medical device development & manufacturing

• Familiarity with related technologies (plastic injection molding, high speed automation)

• Familiarity with medical device/combination product quality & regulatory requirements

• Project Management certification (PMP)

Additional Information:

• Travel 5-15%

• Position location: Indianapolis Lilly Technology Center - North

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