Scientist – TS/MS Sterility Assurance at Lilly

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Title:

Scientist – TS/MS Sterility Assurance 

Responsibilities 

The Scientist in TS/MS Sterility Assurance provide support for contamination control of the Indy RLT manufacturing facility.  They implement and execute sterility assurance related initiatives and provide technical guidance regarding sterility assurance controls. 

Key Objectives/ Deliverables 

• Ensure site’s Environmental Monitoring, Aseptic Process Simulations, Sterilization Processes (i.e. VHP), 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. 
• Create and perform periodic review of environmental monitoring trend data. 
• Create protocols and reports in execution of site sterility assurance programs (i.e. EMPQ, VHP, APS). 
•  Lead or provide technical support for root cause investigations for sterility assurance programs. 
• Use sterility assurance risk management to evaluate existing, proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. 
• Execute and assist in the development of process and facility monitoring strategies that focus on areas of highest microbial risk. 
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements. 
• Create, execute, review and / or approve technical documents related to sterility assurance programs. 
• Create, execute and / or review change controls related to sterility assurance programs. 
• Participate in continuous improvement projects to improve quality performance at the site. 
• Participate or provide guidance for sterility assurance programs during regulatory audits. 
• Maintain a safe work environment by working safely and supporting all HSE Corporate and Site Goals. 

Basic Qualifications 

• Education: minimum educational requirement to perform the position  
• Bachelor’s degree in microbiology, biology, or related scientific field. 

Additional Skills/ Preferences 

• Ability to work independently and with minimal supervision. 
• Knowledge of cGMPs and internal standards 
• Knowledge of microbiology and sterility assurance 
• Ability to apply risk management and use risk assessment tools 
• Experience with trending and analyzing data. 
• Strong technical writing and presentation skills 
• Teamwork / interpersonal skills ability to effectively influence 

Additional Information 

• Pay Grade Level: R1-R4 
• Supervisor: Sr. Manager – TS/MS Sterility Assurance 
• Shift: Day Shift, possible off-shift support. 
• Location: Indy RLT (Onsite) 
• Travel: Occasional travel may be required for training, conferences, or projects. 
• Safety Consideration:  
• Tasks require entering manufacturing areas which require wearing appropriate PPE.  
• Tasks require entering controlled areas where radioactive materials may be present. Special training and exposure monitoring are 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), enAble (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

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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