Senior / Principal Scientist – Sterility Assurance Full-time

Senior / Principal Sterility Assurance Scientist

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.

For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Position Description:

The Senior / 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.

Key Objectives/Deliverables:

• 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, aseptic process simulation program.
• 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.

Minimum Requirements:

• Bachelor's or master's degree in microbiology, biology, biochemistry, or other related scientific discipline.
• Minimum of 2 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.

• 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.

Additional Preferences:

• Possess strong interpersonal skills to work cross-functionally within a team.
• Possess strong self-management and organizational skills.
• Possess strong technical writing 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.

Other Information:

• 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.

The job specification 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 specification.