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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Position Brand Description:

This position will provide leadership for Commercialization Global Program Managers (GPM’s) who lead medical device and drug/device combination product commercialization actives through mid- to late-stage development into manufacturing readiness and commercial launch. The role reports into the Indianapolis Device Manufacturing (IDM) organization, and is responsible for the successful maintenance, execution and optimization of Device Commercialization business processes, working across numerous business units, cross-functional teams in development and manufacturing, and external partners (design partners, injection molding and assembly equipment builders, and contract manufacturers) to develop integrated project schedules for new products and assets. The role will focus on delivery, operational readiness and launch of manufacturing assets, knowledge transfer and technical capabilities, Contract Manufacturer evaluation and selection, CM partner integration and readiness, and gap assessment coordination and resolution.

Key Objectives/Deliverables:

Safety and Quality

Ensure staff is current with all relevant, required training

Drive integration of safe behaviors into daily work by participating in safety initiatives and engagement opportunities, and modeling and reinforcing expectations for safe work practices

Ensure HSE focus as part of Commercialization deliverables and activities, including travel safety

Drive compliance with Lilly standards, policies, and procedures through assessments, quality and compliance audits, and surveillance activities

People

Build and support Development Plans and Career Maps for employees

Assist in identification and mitigation of technical capability gaps across IDM

Identify and leverage contract staffing and consultants to fill capacity and capability gaps

Manage resource workload and allocation across the entire project portfolio

Optimize organizational design/structure and recommendations for the business planning process around staffing levels

Proactively recognize and reward achievements and provide candid feedback for development

Train and certify project team resources and Lilly partners (CM’s, OEM’s and service providers) around Lilly expectations

Plan and optimize team travel to balance business needs and work/life for employees

Business Leadership

Own and execute the Commercialization Business Processes, and drive continuous improvement and optimization of those processes

Establish and implement Commercialization best practices, through after-action reviews, organizational learning, and application of archetype-based project and resource models

Proactively communicate program and team progress to stakeholders, team members, and peers

Partner with Manufacturing Strategy, Platform Senior Directors, IDM Asset Delivery and other functional teams to define robust and executable commercialization strategies and plans

Work with Procurement, Manufacturing Finance, and Device Development teams to establish capital estimates, project budgets, and volume-based COPS targets

Manage and synchronize the teams and functions across sites to enable effective commercialization of new products and capacity expansion for existing platforms

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

Partner with receiving sites (Lilly, Partner or CMO) to establish robust Tech Transfer plans

Develop and communicate department metrics that provide a foundation for continuous improvement

Ensure appropriate allocation of employee time to projects, development, and administrative work

Engage and influence project and process teams to escalate and resolve issues and barriers

Project and Resource Management

Estimate resources needed from all functions to execute commercialization projects

Maintain resource planning models to aggregate resource needs as input to strategic and business planning activities

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

Track and report program metrics for schedule, COPS, scope, capital budget, and resourcing

Encourage and support proactive Design for Manufacturability (DFM), Design for Assembly (DFA), Safety by Design, and Quality principles for all projects and platforms

Benchmark, develop, share, and implement new technology to optimize value and reliability

Minimum Requirements:

5+ years of experience in asset/project delivery and/or medical device development & commercialization

Demonstrated Project Management skills

Familiarity and practical experience with medical device / combination product quality & regulatory requirements, including GMP/CFR, EU MDR, ISO and IEC requirements

Familiarity with related technologies (e.g. plastic injection molding, high-speed automation)

Ability to communicate and influence effectively across functional groups and leadership teams

Strategic thinking and capability

Capability to prioritize and multi-task effectively

Ability to establish and maintain a safe work environment for team and partners

Experience in manufacturing operations and/or manufacturing support functions.

Education Requirements:

BS Engineering or relevant STEM degree

Additional Preferences:

Project Management certification (PMP)

Six Sigma/Lean certification (Black Belt/Green Belt)

Other Information:

Some domestic and international travel required (10-20%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, 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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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