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.
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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products. This is a unique opportunity to be a part of the technical leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.
Responsibilities
The Sr. Principal Scientist/Advisor Validation will be the site technical leader for validation for the Lebanon small molecule, peptide, and oligonucleotide manufacturing plants. In this role you will work collaboratively with peers in the Quality Control Laboratory, Technical Services, Development, Engineering, Operations, and Quality Assurance.
- Define validation strategy for the Lebanon site
- Work effectively and efficiently in a cross-functional team with Quality Control, Quality Assurance, Engineering, and Operations Planning to ensure effective validations
- Author the Validation Master Plan for the Lebanon site
- Anticipate and resolve complex problems. Drive solutions that impact the site.
- Prepare, review, approve, and provide technical support for the preparation of relevant technical documents such as validation protocols, change controls, operating procedures, deviation investigations, plant trial protocols and summary reports, procedures, and technical reports.
- Assist in regulatory filings, as necessary
- Facilitate the risk assessment and experimental and testing plans as needed to perform prevalidation studies.
- Understanding the scientific principles of small molecule and/or peptide manufacturing
Basic Requirements:
- Bachelor's degree in biology, biochemistry, chemistry, chemical engineering, or related scientific discipline
Additional Skills/Preferences:
- Knowledge of validation requirements and good manufacturing and laboratory practices
- Experience mentoring junior staff
- Knowledge of clinical and commercial GMP manufacturing processes
- Strong written and verbal communication skills
- Ability to respond quickly and proactively to changing priorities within a limited timeline
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 ( ) 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
$123,750 - $198,000
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.