For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Responsibilities:

The Sr. Principal Scientist – TSMS Sterility Assurance Floor Leader is responsible for providing technical leadership, management and mentorship for a team of sterility assurance scientists and technical staff while ensuring compliance with regulatory requirements and industry best practices.

Primary objectives include leading and developing a team of sterility assurance scientists (process team) which support floor activities associated with start-up and compliant manufacturing of Concord products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, and sterility assurance risk management. The scope of the role includes syringe filling operations for commercially manufactured products targeted for transfer to the Concord site.

Key Objectives/Deliverables:

• Lead, develop, coach, and mentor a team of sterility assurance scientists (process team) to ensure technical depth and an engaged, inclusive workforce.

• Foster a collaborative workplace and ensure effective hiring and staffing.

• Provide day-to-day oversight for the sterility assurance scientists (process team) associated with routine operations and start-up/project objectives.

• Provide technical expertise and guidance in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies.

• Collaborate cross-functionally with the area process teams for operational support and provide technical guidance for root cause investigations and deviation management.

• Lead sterility assurance related technical projects to improve process control, yield, product quality, and productivity.

• Author, review, and approve site plans, studies, and technical documents related to sterility assurance.

• Use risk management principles to evaluate processes and controls related to sterility assurance.

• Analyze microbial and manufacturing data using statistical principles to identify trends and process disruptions.

• Ensure audit and inspection readiness; support regulatory inspections, submissions, and partner/internal audits.

Basic Qualifications:

• BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline

• Prior experience in cross functional technical leadership roles.

• In depth knowledge of parenteral drug product manufacturing, with a focus on Sterility Assurance

• 5+ years supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance, validation, microbiology, TSMS, QA, etc.)

Additional Skills/Preferences:

• Strong interpersonal and teamwork skills

• Strong self-management and organizational skills

• Strong oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization

• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations

• Demonstrated successful leadership of cross-functional teams

• Experience with data trending and analysis

• Ability to analyze complex data and solve problems

Additional Information:

• This position is tech ladder approved (R4).

• This position will be required to collaborate with peers across the network (Indianapolis, EU, RTP, etc).

• Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and /or off-hour work may be required.