Sr. Principal Scientist - Bioburden and Contamination Control Strategy

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas.  This facility 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 build the processes and facility to enable a successful startup into GMP manufacturing operations.

Description: The Sr Principal Scientist, Contamination Control Strategy is a technical leadership role responsible for designing, deploying, and sustaining a contamination control strategy (CCS) at Lilly's Houston API Manufacturing site. The role ensures the CCS aligns with technical, quality, and regulatory requirements, industry expectations, and business needs, applying data-driven decision-making and innovative technologies to continuously improve contamination control performance. The successful candidate will bring strong knowledge of GMP, pharmaceutical regulatory requirements, and manufacturing operations, and will serve as the TS/MS (Technical Services) business SME on contamination control—partnering closely with process scientists, operations, Quality Control, Engineering, and Quality Assurance to ensure effective cross-functional alignment. Key Objectives/Deliverables Operations across Houston, ensuring CCS integration during Houston API facility start-up and ongoing support through routine GMP manufacturing and post-Process Validation phases. Author, review, and approve technical documents (personnel qualification strategies, control strategies, investigations, change controls, procedures, technical studies) and support global implementation of CCS quality standards and tools. Monitor and maintain cleanroom/controlled environment conditions, including oversight of routine environmental monitoring (EM) activities, in collaboration with site and cross-functional SMEs. Develop statistically based metrics to assess process variability and capability; analyze trending data and prepare reports for management review. Investigate contamination events and deviations, performing root cause analysis and implementing CAPAs. Train staff on contamination control principles, gowning, cleaning/sanitization procedures, and cleanroom behavior. Collaborate with Quality, Engineering, and Operations to assess contamination risks, implement mitigation strategies, and support internal/external audits.

B.S. degree in Pharmacy, Science, Engineering or related STEM field. 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: Deep technical understanding of CCS and regulatory expectations across facilities, production practices, environmental monitoring, and bioburden control. Strong data analysis, critical thinking, and problem-solving skills, with the ability to prioritize and manage multiple competing deadlines in a fast-changing environment. Proven ability to work