Lilly Engineering Project Management Lead (API EM) in Indianapolis, Indiana
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 35,000 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.
For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.
Position Brand Description:
The API External Manufacturing (EM) Engineering and Project Management Lead is a member of the API EM Site Lead Team providing leadership and expertise to reliably supply and commercialize externally manufactured APIs, intermediates and starting materials with safety first and quality always. The role reflects increasing technical complexity and commercialization activity associated with API EM operations as the pipeline portfolio progresses.
Provide API EM organizational Engineering leadership
Coach and mentor engineering associates in aspects of fundamental engineering support, including process knowledge, problem solving and engineering design
Develop and provide ongoing leadership for a Process Safety Management (PSM) program within API EM with the goal of improving PSM capabilities and performance at Contract Manufacturers (CM)
Responsible for ensuring assessments of the HSE and PSM capabilities of each CM impacting Lilly products are completed and maintained
Responsible for ensuring Facility Utility Maintenance Engineer (FUME) assessments of CMs to understand risks presented to Lilly products control strategy are completed and maintained
Lead Lilly internal resources (API EM, ETC, others as required) and partner with CM resources in the execution of HSE, PSM and FUME capability assessments of CMs
Lead internal resources and partner with CMs through specification, procurement, and IQ/OQ/PQ of equipment to ensure capital projects at CMs are delivered on time, within budget and meeting technical expectations
Provide API EM organizational Project Management leadership as a member of the APIEM Site Lead Team, Commercialization Lead Team and Science Lead Team
Develop and sustain a consistent project management planning and execution tracking approach for API EM
Partner with API EM Joint Process Team Leaders and TS/MS Leads to develop robust, risk-assessed, API EM project plans for new product commercialization, technology transfer and major technical agenda projects to meet objectives
Lead the integration of API EM project planning with internal Lilly stakeholder plans (including PDPM, SMDD, BRD, Central TS/MS, GQL, etc) and CM operational plans
Provide project management mentorship and support to Joint Process Team Leaders (who are responsible for project execution and leadership)
Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EM’s CMs.
Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive pharmaceutical manufacturing experience.
7+ years of work experience in a manufacturing operations and process engineering related roles.
Experience in typical unit operations for large molecule expression and purification and small molecule manufacture
Process Hazard Analysis experience
Project management qualifications or demonstrated ability to develop detailed project plans including critical path and risk register analysis
Deep technical knowledge of bulk API manufacturing equipment and unit operations.
Demonstrated ability to apply fundamental chemical engineering principles to process understanding, problem solving, and process improvement.
Demonstrated ability to manage capital delivery project or commercialization / technical agenda projects
Demonstrated ability to understand and influence integration points with other business areas, processes, and functions.
Direct or indirect experience with commercialization (Validation, Tech Transfer, CMC, GMP, Quality, and/or HSE)
Demonstrated ability to function in a team environment as a leader and as a member of teams.
Demonstrated ability to manage and prioritize competing priorities and to appropriately communicate verbally and in writing to various audiences.
The normal schedule for this position is Monday-Friday, 8 hours/day. However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers.
OUS travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing. This travel is typically in the range of 15% to 25% annually, depending on the needs of the projects.
Must complete assigned training curriculum.
No certifications required.
Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!
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