Principal Scientist - 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Principal Sterility Assurance Scientist is a technical role that assists in development and implementation of the site's sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy. The Principal Sterility Assurance Scientist develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to sterility assurance.

• Ensure and provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.
  
• Lead or provide technical oversight for activities related to sterility assurance programs including but not limited to; Airflow Pattern Testing, Environmental Monitoring Performance Qualifications, Aseptic Process Simulations, Cleaning, Sanitization, and Disinfection; Gowning within GMP Classified Areas, Aseptic Processing Techniques, Contamination Control
  
• Lead or assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
  
• Lead/assist with support and/or provide technical expertise for developing the site's contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.
  
• Lead/assist with support and/or provide technical expertise for the facility's cleanroom gowning and aseptic technique strategy/program.
  
• Apply sterility assurance risk management to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
  
• Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities for continuous improvements.
  
• Lead or provide technical support for root cause investigations associated with sterility assurance programs.
  
• Participate and/or provide technical sterility assurance support during internal and external audits.
  
• Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives.
  

Basic Qualifications/ Requirements:

• Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline.
  
• Demonstrated understanding and relevant experience of scientific principles required for manufacturing of parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
  
• 5+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or related dept).
  

Additional Skills/Preferences:

• Possess strong interpersonal skills to work cross-functionally within a team.
  
• Possess strong self-management and organizational skills.
  
• Possess strong oral and written communication skills for communicating to colleagues, management, and other departments.
  
• Experience with data analysis and trending.
  
• Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing, warehouse, or laboratory areas.
  
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
  

Additional Information:

• Role is Monday through Friday based and will be phased from a project support role to a routine support role as the development facility and processes progress. 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.
  
• Tasks may require repetitive motion and standing or walking for long periods of time.
  
• Travel may be required during the project phase for training and implementation of sterility assurance programs
  

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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