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.
Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly’s largest investment in 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.
Position Description:
The Sr Principal Scientist, Contamination Control Strategy is a critical technical leadership role supporting the design, deployment, and sustained operation of a contamination control strategy (CCS) within Lilly’s Lebanon API Manufacturing site. The role ensures strategies align with technical, quality, and regulatory guidance, current industry expectations, and business needs. The successful candidate will build deep technical expertise, apply data-driven decision-making, and continuously improve contamination control performance through innovative technologies.
This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists and engineers play in making medicine and creating real-world solutions. The successful candidate will represent TS/MS (Technical Services) as a business SME working directly with process scientists and operations personnel. This role will partner closely with the production areas to ensure effective cross-functional communication and alignment between the TSMS team, Operations, Quality Control, Engineering, and Quality Assurance.
Key Objectives/Deliverables
- Work directly with CCS Advisor to represent the contamination control aspects of GMP operations across LP1. Ensure CCS integration during Lebanon API facility start-up and continue support through on-going GMP manufacturing.
- Author, review, and approve technical documents including personnel qualification strategies, control strategies, investigations, change controls, procedures, and technical studies. Support global implementation of quality standards and tools for CCS.
- Monitor and maintain cleanroom and controlled environment conditions. Collaborate with site and cross-functional SMEs to ensure robust and compliant control strategies.
- Oversee routine environmental monitoring (EM) activities. Develop and monitor statistically based metrics to assess process variability and capability.
- Provide CCS technical support during start-up and post-Process Validation phases.
- Investigate contamination events and deviations; perform root cause analysis and implement corrective and preventive actions (CAPAs).
- Analyze trending data and prepare reports for management review.
- Train and educate staff on contamination control principles, gowning procedures, room cleaning and sanitization procedures, and cleanroom behavior.
- Collaborate with Quality, Engineering, and Operations teams to assess contamination risks and implement mitigation strategies.
- Support internal and external audits related to contamination control.
Basic Requirements:
- B.S. degree in Pharmacy, Science, Engineering or related field.
- Minimum 6 years industry experience, including 3 years in GMP cleanroom manufacturing experience.
- 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Preferences:
- Demonstrated deep technical understanding of CCS and regulatory expectations for facilities, production practices, environmental monitoring, and bioburden controls.
- Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities.
- Proven ability to work independently and collaboratively within cross-functional teams. Ability to respond quickly and proactively to changing priorities within a limited timeline.
- Demonstrated capability to critically evaluate technical issues, manage multiple priorities, and meet project deadlines.
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
Additional Information:
- Language Requirements: Fluent in English
- This is a fully on-site position located in Lebanon, IN. Standard 8-hour shift, 5 days/week; occasional night and weekend work may be required.
- Travel to other Lilly domestic and international locations generally not exceeding 10%
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.
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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
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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