Job Information
Lilly Associate Director - CMC Program Management 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 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.
Associate Director ; CMC, Device Development Program Manager
Functional Area: Technical Operations
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.
Akouos, a wholly owned subsidiary of Eli Lilly and Company, is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals who live with disabling hearing loss worldwide.
Restoring, improving, and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved pharmacologic therapies to address its underlying causes.
Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy. Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science.
This is a matrix leadership role that collaborates across multiple functions to arrive at a comprehensive CMC development plan. This is a highly visible and influential role in the organization that will interact extensively with line function heads and team members within CMC, Program Team members, and Akouos leadership.
Duties and Responsibilities:
Drive development of CMC operations in collaboration with CMC and program teams. Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule.
Manage multiple device development workstreams supporting design and manufacturing of platform device technology.
Ensure operational plans are proactively tracked and highlight progress towards key milestones to ensure alignment of task dependencies associated with internal and external manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain.
Contribute to program cross-functional working plans and timelines, help teams proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
Utilize processes and tools including scenario planning, gap analysis, decision making and, risk management in collaboration with CMC and device team members, program teams and functional leads.
Provide CMC Project Management for both internal and external CMC development and manufacturing activities. Drive both internal and external timelines to ensure deliverables are achieved on time, within scope, and on budget.
Create, maintain, and articulate for various audiences detailed CMC and device project plans to ensure clarity of deliverables and timing including identifying drivers for each action item.
Coordinate CMC development team, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items.
Manage external CDMOs through development of Statements of Work (SOW) contracts. Provide initial screening and feedback and work with internal technical subject matter experts, legal, finance as required to define scope and budget, drive the negotiation and execution of SOWs, track deliverables.
Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
Basic Qualifications:
5+ years of experience in the biopharmaceutical or biotech industry, with prior experience in a program management role.
Bachelors degree or advanced degree (i.e., Masters, PhD ), preferably in a scientific discipline.
Additional Skills:
Experience with project management tools.
Strong communication, leadership, and collaboration skills are required.
Prior experience as a liaison with external manufacturing organizations.
Previous experience working with internal GMP organization.
Knowledge of cGMP regulations and previous experience working on regulatory filings.
Demonstrated strategic thinking capabilities with forward looking perspective.
Leads without direct reporting responsibility by setting clear vision, respecting value of subject matter expertise, and empowering cross-functional team members to execute.
Solid understanding of drug development, device development, biologics manufacturing, and global operations.
Additional Information:
- Lilly currently anticipates that the base salary for this position could range from between $111,000 to $162,800 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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
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.
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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.
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