Sr. Scientist - Sterility Assurance - Advanced Therapies Manufacturing

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 recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.

Job Description The Sr. Scientist - Sterility Assurance – Technical Services/Manufacturing Scientist (TS/MS) role is a technical position that develops and implements the site’s sterility assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary objectives include the start-up and compliant manufacturing of gene therapy drug product and drug substance, 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.

Key Objectives/Deliverables

• Understand the scientific principles required for manufacturing gene therapy drug products, including the interaction of the chemistry, equipment, aseptic processes, sanitization, and sterilization.

• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.

• Provide technical support on cleaning deviations/events and assist in root cause analysis.

• Provide technical support for all start-up activities related to sterility assurance programs (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.)

• Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level

• Provide technical guidance to the Process Team for sterility assurance programs

• Lead or provide technical support for root cause investigations related to sterility assurance programs

• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements

• Perform periodic review of environmental monitoring data

• Lead or support risk assessments related to sterility assurance programs

• Create, execute, review, and/or approve technical documents related to sterility assurance programs

• Create, execute, and/or evaluate change controls related to sterility assurance programs

• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends

• Participate in continuous improvement projects to improve quality performance at the site

• Participate or provide guidance for sterility assurance programs during internal and external audits, including regulatory inspections, as needed

• Serve as cleaning/sterility assurance interface external to the LP2 site

• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives

• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities

Basic Requirements:

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

• 2+ years of experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance, etc.)

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship 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 visa categories.

Additional Preferences:

• In depth knowledge of gene therapy drug product manufacturing

• 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

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $67,500 - $173,800

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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