Scientist - TS/MS SAT (Secondary Loop) at Eli Lilly and Company

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.

Position Brand Description:

The Sr. Scientist, Principal Scientist and Sr. Principal Scientist positions in the Technical Services / Manufacturing Sciences – Sterility Assurance Technology (TS/MS – SAT) group are positions that provide support for control of the site’s manufacturing facilities.  The group develops and implements sterility assurance related initiatives with regard to sterility assurance strategies.

Key Objectives / Deliverables:

• Responsible for the timely execution of Environmental Monitoring, Aseptic Process Simulation, Facility Cleaning, Facility Sanitization and other Sterility Assurance programs according to procedural and global standards.
• Assists in site aseptic self-inspection program including communication of observations and recommendations for continuous improvement to manufacturing and support personnel.
• Works cross functionally with other functions to coordinate Sterility Assurance initiatives and activities as needed.
• Create and evaluate review of annual environmental monitoring data in addition to other sterility assurance periodic reviews.
• Lead Investigate or provide technical support for root cause investigations for sterility assurance programs.
• Use of 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 including risk assessments, Environmental Monitoring protocols, and summary reports.
• Create, execute and/or review 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 regulatory audits.
• Provide content and/or data integrity reviews for regulatory submissions.
• Lead training courses related to sterility assurance programs.

Minimum Requirements:

• Bachelors Degree in Microbiology, Biology or related scientific field (or equivalent work experience)

Additional Preferences:

• Experience with data trending and analysis
• Analysis and problem-solving skills
• Quality orientation
• Ability to effectively influence

Education Requirements:

• Bachelors Degree in Microbiology, Biology or related scientific field (or equivalent work experience)

Other Information:

• 8-hour days – Monday through Friday
• Overtime may be required
• Work in a dynamic and fast-paced environment
• 5 – 10% Travel Required
• Applicant will work in various areas within the Parenteral Site.  Some allergens are present.
• Applicant may be required to become aseptic certified and to enter in aseptic manufacturing areas for support of activities. Mobility requirements should be considered when applying for this position
• Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.

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Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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