Scientist – TS/MS Sterility Assurance Full-time

Scientist In Ts/Ms Sterility Assurance

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.

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

• Bachelor's degree in microbiology, biology, or related scientific field.

Additional Skills/Preferences

• 2+ years of experience in aseptic manufacturing
• 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

• Travel: Occasional travel (<10%) 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.