Quality Control - Biologist/Microbiology

---

Job description

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 EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly production areas (a 24/7 operation). This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts as a liaison between EM and multiple areas in ownership and/or execution of improvements, projects, and change controls.

Key Objectives / Deliverables:

• Provide technical leadership to EM organization.
• Understand the scientific principles required for manufacturing parenteral drug products, including the components of a robust contamination control strategy.
• Assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk.
• Provide technical support for all start-up activities related to environmental monitoring sampling programs (e.g., environmental monitoring PQ, aseptic process simulations, etc.)
• Ensure site's environmental monitoring, aseptic process simulations, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level, as they pertain to the EM organization.
• Provide technical guidance for environmental monitoring program and for root cause investigations related to this program.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Lead or support risk assessments related to EM program.
• Create, execute, review, and/or approve technical documents related to EM program, including those in support of batch release.
• Continually educate self and others to drive improvements and to remain current with regulatory expectations and industry trends.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring programs
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Minimum Requirements:

• Bachelor's degree in Microbiology, Biology, Biochemistry, or other related scientific discipline
• 8+ years' experience in parenteral manufacturing & environmental monitoring principles

Additional Preferences:

• Strong proficiency in MODA
• Effective written and oral communication skills.
• Effective interpersonal skills
• Experience supporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services/MSAT, quality assurance, etc.)
• Strong self-management and organizational skills
• Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations
• Experience with data trending and analysis
• Ability to analyze complex data and solve problems

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 ( ) 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.

<!– job description page –>