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.
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Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up.
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.
- Knowledge in pharmaceutical Microbiology, related to microbiological media, microbiological enumeration techniques, and microorganism isolation and identification.
- Lead and/or provide technical oversight for developing the site’s Environmental Monitoring program, which includes, but is not limited to:
- Authoring Environmental Monitoring Performance Qualifications (EM PQ) and overseeing the execution.
- Evaluating environmental monitoring data and authoring Environmental Monitoring Trend Reports.
- Assist with identifying facility environmental isolates and how to create and maintain environmental isolate cultures.
- Lead and/or provide technical oversight for developing the site’s Aseptic Process Simulation (APS) program, which includes but is not limited to:
- Authoring Aseptic Process Simulation (APS) protocols and overseeing the execution.
- Evaluating the Aseptic Process Simulation (APS) data, including personnel qualifications, and authoring Aseptic Process Simulation (APS) reports.
- Assist with tracking and tending Aseptic Process Simulations to ensure all regulatory requirements and Global Quality Standards are met for each manufacturing line/process.
- Lead and/or provide technical oversight for developing the site’s contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy strategies.
- Provide technical expertise and/or oversight for the facility’s cleanroom gowning and aseptic technique strategy/program.
- Assist with providing sterility assurance expertise for site procedures, processes, protocols, validations, and technical studies.
- Author and evaluate sterility assurance risk assessments to evaluate manufacturing processes and associated controls with respect to potential introduction of microbial, endotoxin, and particulate contamination.
- Assist in the development and implementation of site process flows to ensure effective contamination control strategies are established.
- 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.
- Create, execute, and/or review/evaluate technical documents and change controls related to sterility assurance programs.
- Work within cross-functional teams to implement TS/MS objective and deliver on business and quality objectives.
- Bachelor’s or master’s degree in microbiology, Biology, Biochemistry, or other related scientific discipline.
- Minimum of 5 years’ experience working in sterile pharmaceutical manufacturing within a Microbiology, Technical Services/Manufacturing Sciences, Sterility Assurance, or other related department with applicable experience in Sterility Assurance programs/strategies.
- 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.
- In depth knowledge of parenteral 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.
- The role will be phased from a project support role to a routine support role as the development facility and processes progress.
- Tasks may require repetitive motion and standing or walking for long periods of time.
- Ability to have a flexible schedule during the project phase to support qualification activities as required.
- Travel may be required during the project phase for training and implementation of sterility assurance programs.
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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.