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.
Overview:
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 are looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced research facility, The Lilly Medicine Foundry, for production of API molecules for clinical trials located in Lebanon, IN. This facility is Lilly's largest investment in a clinical trial manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Note: Final location for this role is Lebanon, IN but flexibility to work from Indianapolis will be required throughout 2025 and 2026.
Position Summary:
The Small Molecule facility is responsible for the manufacture of drug substance (DS) produced via organic synthesis, which includes traditional small molecule medicines at multiple scales as well as high potency antibody drug conjugates.
Associate Director for Small Molecule Process Quality will lead the team responsible for quality oversight of the operations in the Small Molecule facility. The role is also responsible for participating as a cross-functional management team member that provides functional support to Small Molecule operations in meeting the site's operational plan.? This role will be responsible for supporting quality management processes for the Small Molecule facility including review and approval of deviations, change controls, and other records requiring Quality approval. This role will be key to ensuring a strong quality culture and establishing a safety, quality and continuous improvement focused mindset within the Quality team supporting the Small Molecule facility and the broader organization.?
As the Foundry is currently in design and construction, this position will provide Quality oversight as quality and digital processes are designed, developed, and implemented. This position is responsible for monitoring capacity and allocating Quality representatives to provide sufficient support and the project schedule remains on track.
Responsibilities & Scope:
Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
Lead a team of people which includes coaching/feedback for performance and development of QA employees as well as recruiting new talent.
Support the cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
Support the execution of the site operational readiness plan including development of quality processes and approval of operational procedures and controls
Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
Work cross-functionally with the plant teams for metrics reviews, operational support, and issue management
Define and execute inspection readiness activities
Forecast resource needs across the integrated plan and anticipating and resolving any projected resource issues before they impact project delivery.
Facilitate decision making within the team under tight deadlines.
Effectively communicate and manage internal and external stakeholders.
Participate in global communities of practice and committees as appropriate to establish and maintain a network for benchmarking and shared learning.
Identify and lead process improvement projects impacting multiple business areas.
Basic Qualifications:
BA/BS degree in the Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferred.
Relevant industry experience in highly paced working environments. Relevant experience of working on large-scale capital project deliveries is highly desirable.
Strong knowledge of the current GMP expectations and application of quality management systems in execution.
Additional Preferences:
Demonstration of the following:
Experience providing quality oversight for facilities manufacturing clinical and/or commercial drug substance. Experience in synthetic molecule API manufacturing is beneficial.
Project management and delivery of medium to large cross-functional initiatives.
Ability to manage in a dynamic environment. Flexibility to adjust quickly and effectively to frequent change and altered priorities.
Ability to input and influence decision making for complex technical issues.
Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
Experience with networking across industry, such as with industry groups or committees.
Success in coaching, developing personnel, and mentorship.
Ability to establish key relationships and influence peers and business partners.
Strong communication skills.
Ability to identify and prioritize issues, develop, and implement solutions.
High learning agility and ability to deal with ambiguity, uncertainty.
Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis
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 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.
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's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$118,500 - $191,400
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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