Eli Lilly

Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

Eli Lilly$65K — $169K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field.
  • 5+ years of experience in GMP pharmaceutical microbiology or EM, including interaction with regulatory agencies.
  • Proficiency in EM data systems such as MODA and LabVantage.
  • Experience with aseptic manufacturing or sterile drug product operations.
  • Hands-on experience with EM sampling instruments such as Met One and MAS 100.

Responsibilities

  • Own the Cleanroom EM Program as the technical SME, shaping sampling strategy and risk assessments.
  • Coordinate shift-based EM activities in classified production areas, directly supporting manufacturing and addressing environmental concerns.
  • Support EMPQs and utility monitoring readiness for a first-of-its-kind facility.
  • Review and approve EM and lab records, ensuring data integrity and audit readiness.
  • Drive root cause investigations for environmental excursions and manufacturing deviations.
  • Lead team by training and developing EM staff while promoting 'Right First Time' quality culture.
  • Plan resources to optimize work processes and drive continuous improvement in efficiency.

Benefits

  • Comprehensive health coverage including medical, dental, and vision benefits.
  • 401(k) plan and pension options available to employees.
  • Generous vacation benefits and time off.
  • Life insurance and death benefits included.
  • Employee assistance programs and wellness benefits.
Full Job Description
About the Role

The Principal Scientist, GMP EM serves as the technical owner for cleanroom EM and utility monitoring programs supporting GMP manufacturing operations within the Medicine Foundry Analytical GMP Laboratory. This role oversees daily EM team operations, ensures timely and compliant monitoring execution across classified manufacturing areas, and supports contamination control and production readiness. The Principal Scientist provides technical guidance, develops EM technicians and analysts, serves as the primary escalation point for cleanroom and environmental excursions, and partners with Manufacturing, QC, Facilities, and Quality Assurance to maintain inspection readiness. The role also leads and supports root cause investigations and ensures adherence to cGMP, ALCOA+, and applicable quality and regulatory requirements.

What You'll Do

  • Own the Cleanroom EM Program: Serve as the site's technical SME for cleanroom and utility monitoring programs - shaping sampling strategy, risk assessments, alert/action limits, and alignment with the site's contamination control strategy from the ground up.


  • Be a Visible Partner on the Manufacturing Floor: Coordinate shift-based EM activities in classified production areas, support manufacturing operations directly, and respond in real time to production needs and environmental concerns.


  • Drive Readiness for a First-of-Its-Kind Facility: Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities that get manufacturing started - and keep it running at GMP standard.


  • Ensure Data Integrity Across Systems: Review and approve EM and lab records, SOPs, and controlled documents, keeping data accurate and audit-ready in systems like MODA and LabVantage.


  • Keep Equipment and Methods Inspection-Ready: Own instrument qualification, calibration, maintenance, and method readiness so testing never misses a beat.


  • Lead Investigations That Matter: Drive root cause investigations for environmental excursions and manufacturing deviations, partnering across Manufacturing, QA, QC, and Facilities to close CAPAs on time.


  • Champion Inspection Readiness: Keep practices and data aligned with cGMP, FDA, EMA, EU GMP Annex 1, USP , ISO 14644, and 21 CFR 210/211 - and be the one who confidently presents EM data during regulatory inspections.


  • Build the Team: Train, mentor, and develop EM analysts and technicians, instilling aseptic best practices and a "Right First Time" quality culture.


  • Optimize How the Work Gets Done: Plan staffing and resources to meet production schedules, manage budget, and drive continuous improvement in efficiency and cost.


  • Lead by Example on Safety: Ensure all lab, cleanroom, and manufacturing support work is performed safely and in full GMP compliance.


Minimum Qualifications

  • BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field.


  • 5+ years experience in GMP pharmaceutical microbiology or EM experience including experience interacting with regulatory agencies.


  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.


Additional Skills and Preferences

  • Experience with aseptic manufacturing or sterile drug product operations (fill-finish, lyophilization).


  • Proficiency with EM data systems including MODA, LabVantage, Metasys, and quality management systems (TrackWise, Veeva Vault).


  • Hands-on experience with EM sampling instruments: Met One, Climent, Air Ideal, MAS 100, Gas Sampling equipment, Lighthouse, and PMS systems.


  • Working knowledge of microbial identification techniques (MALDI-TOF, Vitek, Gram stain) and bioburden/endotoxin testing.


  • Experience assisting with the development of qualification curricula and on-the-job training plans.


  • Experience working in a greenfield or start-up GMP environment, including contributing to cleanroom qualification, SOP authoring from scratch, equipment selection and qualification, and establishing a quality culture from the ground up


Additional Information

  • Location: Initial location at Parkwood West, Carmel, IN, with occasional work at Lilly Technology Center, Indianapolis. Permanent location at the Lilly Medicine Foundry in Lebanon, IN.


  • Travel: Less than 5% domestic


  • Regular work in controlled cleanroom environments (ISO 5-8 / Grade A-D) requiring gowning per applicable SOP requirements.


  • May require occasional off-hours, weekend, or on-call availability to support critical manufacturing campaigns or investigation response.


  • Physical requirements include standing for extended periods, walking throughout the facility, and performing gowning activities.


Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

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