Sr. Scientist-TS/MS Cleaning Full-time

Sr. Scientist

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.

Patients are at the center of everything we do at Lilly. We are currently hiring a Sr. Scientist.

This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently.

The Scientist—TS/MS Cleaning Validation will provide direct technical support to the cleaning validation program for the fermentation and protein purification manufacturing processes. The candidate will serve as a subject matter expert for the site Cleaning Control Strategy, including the historical and potential failure mode counter measures associated with the cleaning process.

The candidate will be responsible for defining and implementing the routine process monitoring plan, ensuring alignment with the Cleaning Control Strategy so that the cleaning process remains in control and capable. The selected candidate, will be primarily responsible for proactively detecting changes in cleaning data variability and identifying and implementing corrective actions in response. The candidate will be responsible for driving the cleaning improvement agenda, translating cleaning process requirements, and educating Process Teams and operators.

The candidate will participate in the design and execution of Cleaning Validation protocols and reports, Bioburden Control Strategies, and health-based cleaning limit calculations per ICH Q9 and applicable regulatory guidance. The candidate will ensure the cleaning process remains in a validated state through routine monitoring, Manufacturing Campaign Reviews, Ongoing Process Verification (OPV), and Annual Product Reviews (APR). The candidate will be responsible for leading investigations, identifying root causes, defining CAPA plans, and presenting findings to the Deviation Review Board.

The candidate will own change control implementation, which is expected to be completed in an effective and timely manner. The candidate will ensure data integrity and verification procedures are followed and will provide technical support on cleaning processes for new product introduction.

Basic Qualifications

• A bachelor's or master's degree in chemical engineering, or chemistry is required
• A minimum of 5 years of experience in a regulated pharmaceutical or biopharmaceutical manufacturing environment is required, with at least 3 years of direct, hands-on experience in cleaning validation.
• Experience must include authoring or executing cleaning validation protocols and reports, defining cleaning limits (including health-based limits per-ADE methodology), swab and rinse sampling programs, and cleaning process characterization or optimization.
• Experience in fermentation or protein purification manufacturing operations is strongly preferred. Additional relevant experience in Engineering, or Quality functions within pharmaceutical or biologics manufacturing is desirable.
• Knowledge of cGMP regulations (21 CFR Parts 210/211, ICH Q7) and FDA/EMA cleaning validation guidance, including health-based exposure limit (ADE) methodologies.
• Strong technical writing and presentation skills.
• Excellent interpersonal skills that promote engagement and teamwork within cross-functional environment.
• Fully bilingual (English and Spanish).
• Ability to influence; exercise sound judgment.
• Demonstrated leadership skills.
• Ability to manage multiple assignments concurrently in a fast-paced environment with competing priorities.
• Availability to support 24/7 operations.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

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.

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.

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 $52,500 – $132,000.