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Quality Control - Biologist/Microbiology

Employer
Eli Lilly and Company
Location
Durham, North Carolina
Start date
Nov 22, 2024
View more categoriesView less categories
Discipline
Quality, Science/R&D, Biology, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

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 (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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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