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 (ADC,ARC etc.) 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.
Within the PTE organization, the Cleaning and Contamination Control Scientist will provide technical leadership for planning, executing, and continuously improving cleaning and changeover activities at the Lilly Medicine Foundry, ensuring compliance with internal and external standards. Initially focused on developing a strategic cleaning approach to support plant design and operational readiness for production in late 2027, the role oversees equipment cleaning, sampling, and campaign documentation while driving long-term program enhancements through benchmarking and industry alignment. During the design and readiness phase, the scientist will guide equipment and cleaning agent selection, establish GMP-compliant procedures, and collaborate with key stakeholders to transition the site from concept to a clinical trial facility.
Key Responsibilities:
Plant Design/Operational Readiness
- Design and develop the Foundry's cleaning strategy and drive implementation of the site cleaning program.
- Define equipment sets, characterize product groups, select appropriate cleaning agents and cycles, and conduct recovery and cleanability studies to ensure effective and compliant cleaning processes
- Establish cleaning acceptance criteria / carryover limits and collaborate with the analytical laboratory to ensure that analytical methods are appropriate to mitigate risk and maintain patient safety.
- Maintain a comprehensive understanding of the cleaning verification and changeover processes and apply this knowledge to ensure compliance and effectiveness.
- Develop and maintain site Standard Operating Procedures (SOPs), policies, and standardized cleaning documentation to ensure regulatory compliance, operational consistency, and adherence to industry best practices.
- Support the development and ongoing execution of a cleaning and inspection training program for the Foundry.
- Provide support to other Foundry operational readiness workstreams, such as Operations, Quality, Analytical Labs, HSE, and Engineering.
Production Support
- Develop and execute cleaning plans using a risk-based approach for manufacturing equipment and supporting systems.
- Provide support to Operations Process Teams in developing plans and schedules for cleaning activities and equipment changeovers.
- Facilitate remediation activities as required to ensure cleaning processes remain compliant and on schedule, enabling timely return of equipment to service without disruption to production timelines.
- Support the Maintenance Planner by scheduling return to service cleaning into PMs and work orders, including creation of non-routine work instructions.
- Ensure that all cleaning processes and instructions are performed in accordance with HSE requirements
- Participate in safety audits, Process Hazard Reviews, walkthroughs, and floor time programs related to the equipment cleaning process.
- Collaborate with Site Quality to ensure compliance with internal and external cGMP/cGLP equipment cleaning requirements.
- Update, review, and/or approve cleaning related SOPs, instructions, and other related documentation, ensuring adherence to data integrity principles.
- Review and approve all change controls for cleaning program improvements
- Collaborate with cross-functional teams to conduct product impact assessments and apply formal problem-solving methodologies, including root cause analysis, for resolving cleaning-related deviations.
- Lead continuous improvement of the site cleaning program, improving efficiency of cleaning processes and identify program improvements.
Basic Requirements:
- BS or MS in Chemistry, Biology, Biochemistry, Chemical/Biological Engineering, or related disciplines
- BS with 5 years or MS with 3 years experience in qualification/validation of GMP facilities and process equipment in a pharmaceutical/ biopharmaceutical facility. Knowledge of equipment cleaning lifecycle approach and regulatory requirements.
- 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 within a GMP environment.
- Skilled at developing innovative solutions to plant challenges by applying problem-solving techniques and interpersonal strengths, while integrating insights from multiple functional areas
- 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 (< 5%) may be required for this role
- Role requires ability to work in manufacturing and laboratory environments.
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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