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.

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.)

• 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 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.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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), en Able (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

$117,000 - $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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