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.
Organization Overview
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.
Position Overview:
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The Process Translation and Execution (PTE) team translates API/DS process knowledge into clinical supply readiness, oversees technology transfer, implements phase-appropriate control strategies, and ensures right-first-time clinical manufacturing for a variety of modalities, including synthetic molecules, biologics, peptides, oligonucleotide, and bioconjugates. Through cross-functional collaboration, PTE influences process design, revolutionizes clinical manufacturing, builds capabilities in emerging technologies and aligns with corporate and LRL goals, drives scientific excellence and innovation to accelerate manufacturing advancements and propels the site toward long-term business success.
In this role, you will be responsible for establishing and implementing the operational microbiological, contamination control and environmental monitoring programs at the Lilly Medicine Foundry. As the microbiology lead for the facility, the successful candidate will provide technical support for the facility startup defining microbial and viral control strategies in partnership with engineering, operations, quality control and quality assurance. The role will provide support to all GMP areas and will own strategy documents including contamination control, environmental monitoring, and FMEA and response plans. The successful applicant will have a deep technical expertise in their areas of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities. They will also work to continuously improve process efficiency by implementing new technologies and process improvements. They will maximize the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.
Responsibilities
Plant Design/Operational Readiness
- Work with the network and development organizations to ensure a well-understood, robust and fit-for-purpose microbial control strategy is developed and transferred.
- Establish and own the environmental monitoring program, including development of baseline EMPQ protocols and ongoing monitoring.
- Utilize an in-depth knowledge of microbiological controls and associated analytical tests to develop and oversee the contamination control strategy, FMEA and contamination response plan.
- Implement innovative digital solutions to support accelerated manufacturing processes while ensuring compliance and monitoring needs are documented in electronic systems.
- Collaborate as part of cross-functional teams, and establish partnerships with applicable functions, operations and analytical labs to understand interface between the science/engineering with the operations on the floor and bring deep technical expertise to the team.
Production Support
- Create, revise, or review documents such as: SOPs, material specifications, protocols, and trend reports (water, environmental monitoring, etc) and performs investigations as needed.
- Support tech transfer of new entities through assessment of molecule-specific control strategies and critical quality attributes.
- Understand basic statistical methodologies to assign specifications, acceptance criteria, sampling criteria and analysis of batch data for summary reports and product reviews.
- Identify process vulnerabilities and participate in implementation of continuous improvement initiatives.
- Understand and ensure compliance with safety, compliance, and regulatory expectations.
Basic Requirements:
- Minimum BS or MS in microbiology or related discipline.
- 8+ years of experience (BS) or 5+ years of experience (MS) in facility contamination control and environmental monitoring programs in a clinical or GMP manufacturing environment.
- 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
Additional Preferences:
- Capable of collaborating effectively within a team, making autonomous decisions, and influencing a diverse range of groups in a fast-paced environment.
- Strong communication skills, both oral and written to effectively communicate technical information in a clear and concise manner.
- Skilled at developing innovative solutions to plant challenges by applying problem-solving techniques and interpersonal strengths, while integrating insights from multiple functional areas
- Self-starter with high initiative and data-driven approach to problem-solving
- Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
Other Information:
- Initial location at Indianapolis/Carmel location.
- Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
- Limited domestic and international travel (
- Role requires ability to work in manufacturing and laboratory environments.
- As a manufacturing support function, the need for occasional evening or weekend support can arise.
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
$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.
#WeAreLilly
