associate director - automation engineering – control system hw, technology and site support - lilly

associate director, ts/ms manufacturing cmc project management

assistant project manager Jobs in Indianapolis

assistant project manager

associate director - automation engineering – control system hw, technology and site support - lilly Jobs in Indianapolis

associate director - launch leader Jobs in Indianapolis

associate director - launch leader

associate director, ts/ms manufacturing cmc project management Jobs in Indianapolis

principal project engineer Jobs in Indianapolis

principal project engineer

associate director ts ms manufacturing cmc project management

Eli Lilly

<div><p>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&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p><b>
Position Brand Description:</b></p><p>
This role is responsible for integrating Manufacturing CMC elements to support molecule commercialization and to manage the development and implementation of an integrated technical plan for commercially manufactured molecules. This position leads a cross functional team to ensure integrated and innovative CMC plans which accelerate life changing medicines to patients throughout the Manufacturing Life Cycle with safety first and quality always. The role is also responsible for coordinating the Global Product Assessment (GPA) for the molecule(s) which they support. A person in this position would have a CM&amp;C focus, be expected to apply Project Management principles, provide decision-making leadership for a cross functional team, and participate in process improvement activities within Manufacturing.
</p><p></p><p><b>Key Objectives/Deliverables</b></p><p>
Team Leadership</p><ul><li>
Responsible for leading a Development and Manufacturing (central and site) team of moderate to high complexity and scope through development and execution of project plans that deliver strategic and operational objectives.
</li><li>Support the Development CM&amp;C teams in developing strategies and implementing operational plans to deliver required materials (such as API, drug product formulations, registration stability lots, clinical trial materials, etc.) as needed to support a particular project.
</li><li>Influence Development Manufacturing Technical Agenda and pre submission deliverables to enable effective transition to downstream Manufacturing plan/deliverables.</li><li>
Develop and manage an integrated Post Launch Technical Agenda for assigned molecules to support launch/commercial needs, reliable supply and productivity objectives.</li><li>
Responsible for the integration of the team plan to achieve Life Cycle Management objectives.</li></ul><p></p><p>
Project Management Leadership</p><ul><li>
Responsible for delivery of project milestones on time and within scope through the utilization of project management approaches and tools.
</li><li>Document key team information and decisions and ensure project management systems are up to date.</li><li>
Encourage appropriate risk taking within the team by leading risk assessments and contingency planning at the team level.</li><li>
Resolve team issues with Manufacturing priorities in mind.</li><li>
Ensure strategic alignment with key stakeholders.</li><li>
Support upward and cross-functional communications.</li><li>
Actively track leading indicators of teams&rsquo; progress to major milestones.</li><li>
Build and maintain effective teams: motivate, recognize, coach &amp; mentor team members and associates.</li><li>
Gain and share learning and optimized practices within and across teams.</li></ul><p></p><p>
Governance Facilitation and Reporting</p><ul><li>
Responsible for facilitating Manufacturing Reviews and other governance alignment
</li><li>Ensure reporting of project status, metrics, and risk. Escalate as necessary.
</li><li>Coordinate Global Product Assessments (GPAs), with Technical Stewards and Manufacturing sites, to ensure holistic review of control and capability of the manufacturing processes.</li></ul><p></p><p>
Functional Leadership</p><ul><li>
Mentorship of peers and team members
</li><li>Support process improvement</li><li>
Subject Matter Expert of a process or system</li></ul><p></p><p><b>
Basic Requirements:</b></p><ul><li>
Minimum 5 to 10 years&rsquo; experience in more than one Pharmaceutical Development CM&amp;C function OR Pharmaceutical Manufacturing function/site</li><li>
Demonstrated leadership of cross-functional teams</li><li>
Demonstrated project management experience</li><li>
Demonstrated knowledge of CM&amp;C aspects of Commercialization and Commercial Manufacturing</li><li>
Strong interpersonal and teamwork skills</li><li>
Strong oral and written communication skills</li><li>
Strong problem-solving skills, self-management and organizational skills.</li><li>
BSc Required. MSc in Chemistry, Biology, Engineering, Project Management, or MBA preferred.</li></ul><p></p><p><b>
Additional Preferences:</b></p><ul><li>
Demonstrated knowledge of CM&amp;C aspects of Pharmaceutical Drug Development</li><li>
Experience in Technical Services/Manufacturing Services, Manufacturing Operations, and/or QA/QC within Pharmaceutical Manufacturing highly desirable.</li><li>
Experience with Smartsheet as a Project Management tool.</li><li>
Master&rsquo;s in project management, PMP Certification, or MBA preferred.</li></ul><p></p><p><b>
Other Information:
</b></p><ul><li>Some travel (domestic and international) may be required. Less than 5%</li></ul><p>
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.</p><p></p><p>
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p><br>
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p></p><p>
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
$117,000 - $171,600<p></p><p>
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p></p><p>
#WeAreLilly</p></div>

Associate Director, TS/MS Manufacturing CMC Project Management

Information Technology Senior Management Forum

<div><div><p>Posted Date</p>
<p>4/28/2026</p>
</div><div><p>Description</p>
<div><p>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&rsquo;re looking for people who are determined to make life better for people around the world.</p>
<p>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&rsquo;re looking for people who are determined to make life better for people around the world.</p>
<p><b>Organization and Position Overview</b></p>
<p>Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.</p>
<p>The Associate Director-Automation Engineering - Control System HW, Technology and Site Support is responsible for the supervision of the Automation Hardware, I&amp;C, Site support function that support the daily operations of the facility and managing the overall Automation technology support. The Associate Director is also responsible for the productivity and development of the employees with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Associate Director partners to influence and implement within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.</p>
<p>In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up.</p>
<p>Responsibilities:</p>
<p><b>Key Objectives/Deliverables:</b></p>
<ul><li>Administrative Leadership</li></ul>
<ul><li>Supervise and lead the Hardware, I&amp;C and Automation site support team, including completing performance reviews and development plans.</li></ul>
<ul><li>Responsible for the Automation Technology management to deliver Automation team milestones and projects.</li></ul>
<ul><li>Staffing, including recruiting, resource planning, and succession planning.</li></ul>
<ul><li>Process validation work coordination.</li></ul>
<ul><li>Review and monitor financial performance; commit to meeting targets</li></ul>
<ul><li>Actively participate and support the Automation Engineering Operations and Training Program</li></ul>
<ul><li>Develop Project, Program and Initiatives execution metrics with analytics team.</li></ul>
<p><b>Operational Excellence</b></p>
<ul><li>Demonstrate a commitment to environmental, health, and safety</li></ul>
<ul><li>Identify, track, and report key indicators of functional performance</li></ul>
<ul><li>Ensure team is operating in a state of compliance</li></ul>
<p><b>Organizational Capability</b></p>
<ul><li>In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.</li></ul>
<ul><li>Assure focus by engineers and completion of critical assignments with appropriate monitoring and reporting</li></ul>
<ul><li>Ability to instill teamwork within the department and demonstrate key interpersonal skills.</li></ul>
<ul><li>Ability to ensure appropriate technical depth and rigor with departmental technical deliverables.</li></ul>
<ul><li>Ability to make decisions independently and to network with others as appropriate.</li></ul>
<ul><li>Ability to function in a team environment as a leader and as a member of management teams.</li></ul>
<p><b>Basic Requirements:</b></p>
<ul><li>Minimum B.S. in Engineering and ten years' experience in Site Support, Hardware Instrumentation, Project and Portfolio management, preferably in pharmaceutical manufacturing</li></ul>
<ul><li>Experience in leading major projects from design, development, commissioning to qualification.</li></ul>
<p><b>Additional Preferences:</b></p>
<ul><li>Experience in design, development, commissioning and qualification of control and network panels, loop checks, IQ in a highly automated greenfield manufacturing site.</li></ul>
<ul><li>Experience in design, development, commissioning and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, QMS, Site Historian systems (DeltaV, Rockwell, Syncade, Veeva, OSI PI,).</li></ul>
<ul><li>Experience in developing and implementing an operational site support structure for day-to-day operations in a running plant.</li></ul>
<ul><li>Experience as a member of the group leadership in running the plant, including participation in management sub-teams.</li></ul>
<ul><li>Successful application of organizational models through recruiting and retention of employees.</li></ul>
<p><b>Other Information:</b></p>
<ul><li>Initial location at Parkwood West, Indianapolis, Indiana.</li>
<li>Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.</li>
</ul>
<p>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.</p>
<p>Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p>
<p>Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p>
<p>Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
<p>$123,000 - $180,400</p>
<p>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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p>
<p>#WeAreLilly</p></div>
</div><div><p>Salary</p><p>
123,000.00 - 180,400.00 Annual</p></div></div><div></div>

Associate Director - Automation Engineering – Control System HW, Technology and Site Support - Lilly

<div><p>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&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p><b>
Organization Overview:</b></p><p></p><p>
The Associate Director &ndash; Launch Leader will participate in the development and implementation of manufacturing strategies, capacity management projects, and launch of new products for the Indy Device Assembly and Packaging (IDAP) site. The Associate Director &ndash; Launch Leader will represent IDAP in discussions with external groups (e.g. corporate supply chain, other network sites, sales and marketing affiliates, etc.) through various forums and meetings to support development of Site and Network plans. The Associate Director &ndash; Launch Leader will also be required to lead or participate in special projects in support of the Site and Logistics Department.</p><p></p><p><b><br>
Responsibilities:</b></p><ul><li>
Develop and propose manufacturing strategies related to Parenteral, Dry or Device products</li><li>
Manage site product portfolios: capture and pursue business opportunities / challenges</li><li>
Influence and provide support for Site Business and Long-Range Plans</li><li>
Support Site and Global S &amp; OP processes</li><li>
Introduction and deletion of products and pack changes</li><li>
Outsourcing or product deletion management</li><li>
Serve as the site SME for supply chain projects and support enhancements to Supply capabilities</li><li>
Assist in special projects or improvement opportunities as identified</li><li>
Support Commercialization Projects within IDAP and IPM</li></ul><p></p><p><b><br>
Basic Requirements:</b></p><ul><li>
Bachelor's degree or equivalent work experience.</li><li>
Demonstrated Project Management skills.</li><li>
Experience with SAP.</li><li>
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.</li></ul><p></p><p><b><br>
Additional Skills/Preferences:</b></p><ul><li>
Preference for candidate with Parenteral Products, Dry Products, or Device experience</li><li>
Ability to communicate and influence effectively across functional groups</li><li>
Strategic thinking and capability</li><li>
Capability to prioritize and multi-task effectively</li></ul><p></p><p><b>
Additional Information:</b></p><ul><li>
Travel 0-5 %</li><li>
Shift information - Day shift, but flexible to meet with global affiliates during off hours due to time zone differences.</li><li>
Position location - Indianapolis - LTC-S</li></ul><p></p><p>
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.</p><p></p><p>
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p><br>
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p></p><p>
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
$127,500 - $187,000<p></p><p>
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p></p><p>
#WeAreLilly</p></div>

Associate Director - Launch Leader

<div><p>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&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p>
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.</p><h2 class="jobSectionHeader"><b>
Position Overview:</b></h2><p></p><p>
Delivery, Devices, and Connected Solutions (DDCS) sits within Eli Lilly's Product Research &amp; Development organization. We are a diverse team of scientists and engineers responsible for discovering, designing, and developing patient-centric drug delivery solutions across a broad range of modalities &mdash; from injection devices to novel routes of administration and nanomedicines. DDCS drives the drug delivery innovation agenda across early and late development to meet the needs of an expanding portfolio that spans small molecules, biologics, and nucleic acid therapeutics.<br>
<br>
DDCS is organized around a matrix model with strong disciplinary and functional horizontals supporting innovation and commercialization verticals. Our vision is to get our medicines to more patients faster by accelerating reach and scale, guided by three strategic pillars: Delivery Systems, Robust &amp; Sustainable, and Patient Experience + Outcomes.</p><p><br>
The Drug-Device Combination Product (ddCP) Development Engineering horizontal within DDCS bridges device platform expertise with CMC drug product development, enabling combination product submissions and launches across innovation and commercialization verticals. This team is accountable for design control execution, device-drug integration studies, and technical packages supporting Lilly's global regulatory submissions.</p><p>
The Development Engineer for Drug-Device Combination Products (ddCP) is a technical specialist responsible for executing design control activities, device-drug integration studies, and combination product development work to support clinical and commercial programs. Reporting to the Team Leader, Development Engineering &ndash; ddCP, this individual contributor role operates within the DDCS matrix, requiring strong technical expertise in device engineering, design controls, and regulatory compliance while building skills in cross-functional leadership, business operations, and strategic thinking.</p><h2 class="jobSectionHeader"><b>
Responsibilities:</b></h2><p></p><p><b>
CP Risk Management &amp; Development Strategy</b></p><ul><li><p>
Conduct molecule-specific risk assessments per ISO 14971, incorporating drug product safety profiles, device failure modes, and patient use scenarios.</p></li><li><p>
Evaluate device technology platform suitability for clinical molecules considering technical feasibility, business implications, and supply chain factors.</p></li><li><p>
Perform comprehensive assessments of device options; provide data-driven recommendations considering regulatory pathway, timeline, cost, and commercial viability.</p></li><li><p>
Update risk assessments throughout product lifecycle, contributing insights to portfolio management decisions.</p></li></ul><p><b><br>
Device Design Control Execution</b></p><ul><li><p>
Execute molecule-specific design control activities for assigned combination product programs in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.</p></li><li><p>
Develop and maintain molecule-specific Design History Files (DHF) including design inputs, design outputs, verification protocols, and traceability matrices.</p></li><li><p>
Author design requirements specifications incorporating drug product characteristics, delivery requirements, patient population needs, and regulatory requirements.</p></li><li><p>
Ensure DHF completeness and adequacy to support regulatory submissions and manufacturing activities.</p></li></ul><p><b><br>
Integrated Control Strategy &amp; Regulatory Readiness</b></p><ul><li><p>
Develop integrated control strategies encompassing device specifications, drug product specifications, and combination product performance attributes.</p></li><li><p>
Author platform rationale documents supporting regulatory submissions across regions (FDA, EMA, PMDA, NMPA).</p></li><li><p>
Monitor regulatory landscape for combination products; partner with Regulatory Affairs to understand strategy and participate in submission planning.</p></li></ul><p><b><br>
Stability Study Design, Execution &amp; Insights</b></p><ul><li><p>
Design combination product stability studies aligned with ICH guidelines and regional regulatory requirements.</p></li><li><p>
Coordinate stability programs across stakeholders; analyze data and trends to inform decisions on shelf-life, storage conditions, and 'fit for use' rationale.</p></li><li><p>
Contribute to development of stability testing strategies and organizational standards.</p></li></ul><p><b><br>
Clinical Supply &amp; Regulatory Submission Support</b></p><ul><li><p>
Author technical sections for regulatory submissions (NBOp, IND, NDA, BLA, MAA) in CTD/eCTD format.</p></li><li><p>
Compile and review technical data packages; respond to regulatory questions and information requests.</p></li><li><p>
Support regulatory inspections by providing technical expertise and documentation.</p></li></ul><p><b><br>
Cross-Functional Leadership &amp; Business Operations</b></p><ul><li><p>
Partner with CMC functions, Regulatory Affairs, Quality, and Manufacturing across the DDCS matrix.</p></li><li><p>
Work with device suppliers and contract manufacturers to ensure supply chain readiness for clinical trials.</p></li><li><p>
Participate in portfolio reviews, resource planning, and strategic prioritization discussions.</p></li><li><p>
Explore and pilot AI/ML applications, digital tools, and data analytics to improve development processes.</p></li><li><p>
Mentor junior team members and contribute to training programs.</p></li></ul><h2 class="jobSectionHeader"><b>
Basic Requirements:</b></h2><ul><li><p>
Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Materials Science), Pharmaceutical Sciences, or related technical discipline</p></li><li><p>
7+ years of experience in pharmaceutical/biotechnology product development, medical device development, or combination product development.</p></li><li><p>
Familiarity with drug product formulation, biologics development, ICH guidelines, GMP/GxP requirements, and/or regulatory submission preparation.</p></li><li><p>
Regulatory awareness and quality mindset in GMP/GxP environments</p></li><li><p>
Excellent communication skills with ability to present technical information to diverse audiences and influence across matrix organizations without formal authority.</p></li><li><p>
Learning agility and initiative in a fast-paced, high-growth environment</p></li><li><p>
Strategic thinking that connects technical work to portfolio and business outcomes</p></li></ul><h2 class="jobSectionHeader"><b>
Additional Preferences:</b></h2><ul><li><p>
Master's degree in Engineering, Pharmaceutical Sciences or related discipline with 5+ years of experience as listed above, OR PhD/PharmD with 2+ years of experience as listed above</p></li><li><p>
Business acumen with interest in portfolio management, resource planning, and strategic decision-making.</p></li><li><p>
Project management experience: timeline management, resource coordination, process improvement (Lean, Six Sigma), digital tools (AI/ML, GenAI).</p></li><li><p>
Technical execution in device design controls, combination product development, and regulatory submissions</p></li><li><p>
Cross-functional collaboration within the DDCS matrix model</p></li><li><p>
Analytical rigor and data-driven problem solving</p></li></ul><h2 class="jobSectionHeader"><b>
Additional Information</b></h2><ul><li><p>
Travel: 5&ndash;15%</p></li><li><p>
Location: Indianapolis, IN; Lilly Technology Center &ndash; North (LTC-N)</p></li></ul><p>
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.</p><p></p><p>
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p><br>
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p></p><p>
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
$126,000 - $204,600<p></p><p>
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&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p></p><p>
#WeAreLilly</p></div>

Development Engineer, Drug-Device Combination Products (ddCP)

Indiana University

<p></p><div><div><div><div><div><div><div>The Indiana University School of Dentistry is currently recruiting for a Director for our Dental Public Health Programs within our department of Dental Public Health and Dental Informatics. This is a full-time (1.0 FTE) tenure-track position at the rank of assistant professor. Only candidates with specialty training in public health or a related field and a minimum of four years of experience in public health settings are invited to apply. Review of applicants will begin immediately with an anticipated position start date of July 1, 2026, or sooner.<br>
<br>
Our department of Dental Public Health and Dental Informatics has had a strong community-based education focus for decades. Our specific strengths are in the areas of community engagement, applied dental public health practice, and community-based oral health prevention programs. We are aiming at enhancing the focus of these educational programs. Hence, the director of our Dental Public Health Programs will oversee, develop, and maintain robust community-based rotations and programs for our students; effectively collaborate with oral health care providers working in community settings; oversee, develop, and maintain select community engagement and service-learning programs; and coordinate with public health agencies and partners in support of departmental priorities. Moreover, as a tenure-track faculty member, our Director will be involved in didactic and clinical instruction in Dental Public Health and related subject areas at the predoctoral and graduate levels, including serving as course director or co-director for Dental Public Health and community-based courses. The Director will provide leadership for Community-Based Dental Education (CBDE) and related community engagement activities, including the coordination and oversight of partnerships with community organizations, public agencies, and clinical sites that support educational and service activities. The Director will also advise and mentor predoctoral and graduate students engaged in public health, research, and community-based work. Additional responsibilities will include scholarly activity, program evaluation, and peer-reviewed publication, as well as engagement in university service at the department, school, and university levels. Regular travel within the state of Indiana is required.<br>
<br>
As the state&rsquo;s premier urban research institution, Indiana University is committed to being a welcoming campus community. As a member of that community, the IU School of Dentistry seeks candidates whose teaching, service, scholarship, research and community engagement efforts contribute to robust learning, working, and patient care environments. This commitment is core to our mission through our school-owned clinics and educational programs in Indianapolis and Fort Wayne, Indiana.</div><div>
</div><div>
IUSD offers a dynamic learning environment for faculty, in which teaching, research, clinical care, and community service are core to our mission through our School-owned clinics and educational programs in Indianapolis and Fort Wayne, Indiana. Our main facility includes a state-of-the-art 45,000&ndash;square-foot James J. Fritts DDS Clinical Care Center on the IU-Indianapolis campus, adjacent to local hospitals and part of an urban academic health center.</div></div>
</div><br>
<div><div><b>Basic Qualifications</b></div>
<div><div>To be successful in this position, at the time of application the candidate must possess each of the following:</div><ul>
<li>A minimum of four years of experience working in public health and advanced graduate education.</li>
<li>Either a DDS or DMD from a CODA-accredited program or equivalent.</li>
<li>Current dental licensure or eligibility for dental licensure in the state of Indiana by July 1, 2026.</li>
<li>Current experience in the development and implementation of community-based dental education, community/academic partnership&rsquo;s creation, and teaching within all areas noted for this position.</li>
<li>Evidence of experience in financial management, quality assurance, and program evaluation.</li>
Grant writing and management experience.<br>
<li>
</li>
</ul></div></div><br>
<div><div><b>Department Contact for Questions</b></div>
<div><div>Dr. E. Angeles Martinez-Mier</div><div>
Associate Dean for Global Engagement</div><div>
Department Chair, Dental Public Health and Dental Informatics</div><div>
IU School of Dentistry</div><div>
<b>esmartin@iu.edu</b></div></div>
</div><br>
<div><div><b>Additional Qualifications</b></div>
<div>An MPH, MS, MSD, PhD, DPH or related degree as well as a certificate of specialty study in public health is strongly preferred.</div>
</div><br>
<div><div><b>Salary and Rank</b></div> <div>Salary and rank will be commensurate with qualifications and experience.</div>
</div><br>
<div><div><b>Special Instructions</b></div>
<div><div>This posting will be open until filled. Interested candidates should review the application requirements below:</div><ul>
<li>Signed letter of intent</li>
<li>Complete curriculum vitae</li>
Names of three professional references with contact information. (When requested, submitted reference letters must be provided on letterhead with the referee&rsquo;s signature.)<br>
<li>
</li>
</ul></div></div><br>
<div><div><b>For Best Consideration Date</b></div> <div>03/31/2026</div>
</div><br>
<div><div><b>Expected Start Date</b></div> <div>07/01/2026</div>
</div><br>
<div><div><b>Posting Number</b></div> <div>IU-101503-2026</div></div></div></div></div></div>

Director of the Dental Public Health Program

Rolls-Royce

<div><div><div><div><div><div><div><div><h2 class="jobSectionHeader"><b>Job Description
</b></h2></div></div></div></div></div></div></div><p><b>Job Title: </b>Supply Chain Change Project Manager
</p><p><b>Working Pattern: </b>Full time
</p><p><b>Working location: </b>Indianapolis, IN (Hybrid &ndash; 3 days in office)
</p><p></p><p>The Supply Chain Change Project Manager will have responsibility for owning and leading supply chain change projects (parts transfers or other similar activity) as assigned by the Supply Chain Change Project Executive in accordance with Advanced Product Quality Planning (APQP). This will provide the ideal opportunity to develop and execute plans that meets Supply Chain Unit expectations and goals.
</p><p></p><p><b>Why Rolls-Royce?
</b></p><p>Rolls-Royce is one of the most enduring and iconic brands in the world and has been at the forefront of innovation for over a century. We design, build and service systems that provide critical power to customers where safety and reliability are paramount.
</p><p></p><p>We are proud to be a force for progress, powering, protecting and connecting people everywhere.
</p><p>We want to ensure that the excellence and ingenuity that has shaped our history continues into our future, and we need people like you to come and join us on this journey.
</p><p></p><p>Rolls-Royce has been recognized as the top employer in the <b>Engineering &amp; Manufacturing </b>category on the prestigious <b>Forbes Top Employers for Engineers </b>list for 2025. This ranking highlights our commitment to innovation, employee development, and fostering a collaborative environment where engineers can thrive.
</p><p></p><p>Be part of a team that sets the industry standard and drives groundbreaking solutions.
</p><p>At Rolls-Royce, we are committed to creating a workplace where all employees feel respected, supported, and empowered to do their best work. We foster a welcoming and innovative work environment that invests in you, giving you access to an incredible breadth and depth of opportunities where you can grow your career and make a difference.
</p><p></p><p>Rolls-Royce is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any protected characteristics.<br>
</p><p><br>
<b>What you will be doing
</b></p><ul><li>Lead cross functional project teams to deliver change activities on time at expected cost in support of supply chain strategy
</li><li>Monitor, manage, and drive project performance utilizing sound project management practice
</li><li>Provide verbal and written progress reports to stakeholders as required
</li></ul><p></p><p><b>Who we&rsquo;re looking for:
</b></p><p>At Rolls-Royce we put safety first, do the right thing, keep it simple and make a difference. These principles form the behaviors that guide us and are an essential component of our assessment process. They are the fundamental qualities that we seek for all roles.
</p><p></p><p><b>Basic Qualifications:
</b></p><ul><li>Associates Degree in Engineering or Supply Chain Management and 7+ years&rsquo; experience in Project Management, New Product Introduction, Manufacturing Engineering and/or Procurement/Supplier Management, OR
</li><li>Bachelor&rsquo;s Degree in Engineering or Supply Chain Management and 5+ years&rsquo; experience in Project Management, New Product Introduction, Manufacturing Engineering and/or Procurement/Supplier Management, OR
</li><li>Master&rsquo;s degree in Engineering or Supply Chain Management and 3+ years&rsquo; experience in Project Management, New Product Introduction, Manufacturing Engineering and/or Procurement/Supplier Management, OR
</li><li>JD/PhD, OR
</li><li>In lieu of degree, 9+ years&rsquo; experience in Project Management, New Product Introduction, Manufacturing Engineering and/or Procurement/Supplier Management.
</li><li>To be considered for this opportunity you must be U.S. Citizen/Permanent Resident
</li></ul><p></p><p><b>Preferred Requirements:
</b></p><ul><li>PMP Certification
</li></ul><p></p><p><b>What we offer:
</b></p><p>We offer excellent development opportunities, a competitive salary, and exceptional benefits. These include bonus, employee support assistance and employee discounts.
</p><p></p><p>Your needs are as unique as you are. Hybrid working is a way in which our people can balance their time between the office, home, or another remote location. It&rsquo;s a locally managed and flexed informal discretionary arrangement. As a minimum we&rsquo;re all expected to attend the workplace for collaboration and other specific reasons, on average three days per week.
</p><p></p><p>Relocation assistance is not available for this position.<br>
</p><p></p><div><div><div><div><div><div><div><h2 class="jobSectionHeader"><br>
<b>Job Category
</b></h2></div></div></div></div></div></div></div>Project Management
<div><div><div><div><div><div><div><h2 class="jobSectionHeader"><br>
<b>Job Posting Date
</b></h2></div></div></div></div></div></div></div>28 Apr 2026; 00:04
<div><div><div><div><div><div><div><h2 class="jobSectionHeader"><br>
<b>Pay Range
</b></h2></div></div></div></div></div></div></div>$114,400 - $185,900-Annually<br>
<div><div><div><div><div><div><div><p><br>
<b>Location:
</b></p></div></div></div></div></div></div></div>Indianapolis, IN<br>
<p><br>
<b>Benefits
</b></p><p>Rolls-Royce provides a comprehensive and competitive Total Rewards package that includes base pay and a discretionary bonus plan. Eligible employees may have the opportunity to enroll in other benefits, including health, dental, vision, disability, life and accidental death &amp; dismemberment insurance; a flexible spending account; a health savings account; a 401(k) retirement savings plan with a company match; Employee Assistance Program; Paid Time Off; certain paid holidays; paid parental and family care leave; tuition reimbursement; and a long-term incentive plan. The options available to an employee may vary depending on eligibility factors such as date of hire, employment type, and the applicability of collective bargaining agreements.</p></div>

Supply Chain Change Project Manager

<div><p><b>Project Engineering at V2X:</b> Project Engineering is a specialized field within engineering that focuses on planning, managing, and executing projects. It combines technical expertise with project management skills to successfully achieve project objectives. Project Engineering demands a robust understanding of the project life cycle and its deliverables. Project engineers possess extensive engineering experience, particularly in the development and execution of engineering projects.</p>
<p><b>
Role Overview:</b> V2X is growing! The Project Engineering Department is seeking a <b>Project Engineering Lead (PEL)</b> for our Platform Systems Integration (PSI) Section in Indianapolis. The PEL provides senior technical leadership for a complex, strategically important program requiring strong cross-functional coordination and disciplined execution. This role is responsible for unifying diverse stakeholder perspectives into a cohesive engineering strategy, establishing rigorous technical management frameworks, and ensuring effective integration across a diverse set of specialized teams. Operating with broad autonomy, the successful candidate will guide decision making, drive technical risk management, and provide expert oversight on supplier engagements. This position demands exceptional strategic judgement, cross-disciplinary expertise, and the ability to maintain alignment in a dynamic engineering environment.</p>
<p><b>
Key Responsibilities:</b></p>
<ul>
<li>Establish and oversee technical management frameworks across engineering disciplines.</li>
<li>Lead the most complex technical projects, ensuring cross-disciplinary integration of mechanical, electrical, software, and manufacturing engineering.</li>
<li>Provide authoritative guidance on supplier management, contract negotiations, and technical compliance.</li>
<li>Develop and implement decision management methodologies, including trade studies, cost-benefit analysis, and engineering problem-solving.</li>
<li>Drive technical risk management, ensuring proactive identification and mitigation of engineering uncertainties.</li>
<li>Shape department-wide policies, ensuring alignment with IEEE 15288, PMI PMBOK, ISO 9001, and AS9100 standards.</li>
<li>Lead agile transformation efforts, optimizing engineering workflows and stakeholder collaboration.</li>
<li>Mentor engineers at all levels, fostering a culture of technical excellence and innovation.</li>
<li>Represent the organization in industry forums, technical committees, and executive strategy meetings.</li>
<li>Forecast future engineering staffing needs and optimize workload distribution to support engineering-wide resource planning.</li>
<li>Responsible for defining and improving technical project execution methodologies to ensure alignment with department objectives.</li>
<li>Establishes department-wide estimation frameworks, defining best practices for cost modeling, proposal development, and resource forecasting to drive technical and financial success.</li>
<li>Provides expert oversight on engineering proposals, ensuring technical accuracy, feasibility, and competitive positioning in alignment with business strategy.</li>
<li>Serve as an Independent Technical Reviewer for projects, providing objective assessments of technical decisions, risk mitigation strategies, and compliance with engineering standards to ensure project success.</li>
</ul>
<p><b>Required Qualifications:</b></p>
<ul>
<li>Bachelor&rsquo;s degree in Engineering or related field.</li>
<li>15+ years of engineering or project management experience.</li>
<li>Expert proficiency in Microsoft Office, Microsoft Project, and risk management tools.</li>
</ul>
<p><b>Technical Skills:</b></p>
<ul>
<li>Expert understanding of IEEE 15288, PMI PMBOK, and ISO 9001.</li>
<li>Advanced knowledge of Azure, Jira, Windchill, and GitHub.</li>
<li>Deep expertise in mechanical, electrical, software, or manufacturing engineering disciplines.</li>
</ul>
<p><b>Soft Skills:</b></p>
<ul>
<li>Industry-leading expertise and strategic vision.</li></ul></div>

Principal Project Engineer

Explore 314+ Associate director ts ms manufacturing cmc project management in Indianapolis this May. Find roles across top companies and apply now to boost your career.