Principal Scientist GMP Environmental Monitoring Lilly Medicine Foundry

Lilly • Indianapolis, IN

2d • $65,250 - $169,400

About The Position

The Principal Scientist, GMP Environmental Monitoring is the technical owner for cleanroom environmental monitoring (EM) and utility monitoring programs supporting GMP manufacturing operations within the Lilly Medicine Foundry Analytical GMP Laboratory. The role oversees daily EM team operations, ensures timely and compliant monitoring across classified manufacturing areas, and supports contamination control and production readiness. It 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 leads and supports root cause investigations and ensures adherence to cGMP, ALCOA+, and applicable quality and regulatory requirements.

The position will establish and shape cleanroom and utility monitoring strategy, including sampling plans, risk assessments, alert/action limits, and alignment with the site's contamination control strategy. It supports EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities; reviews and approves EM and laboratory records, SOPs, and controlled documents; and maintains instrument qualification, calibration, maintenance, and method readiness. The role also presents EM data during regulatory inspections, develops team capability and aseptic practices, and manages staffing, resources, budgets, and continuous improvement.

The initial work location is Parkwood West in Carmel, Indiana, with occasional work at the Lilly Technology Center in Indianapolis. The permanent location will be the Lilly Medicine Foundry in Lebanon, Indiana. Domestic travel is less than 5%. The role involves regular work in controlled cleanroom environments (ISO 5–8 / Grade A–D), with gowning according to applicable SOPs. Occasional off-hours, weekend, or on-call availability may be required for critical manufacturing campaigns or investigation response. Physical requirements include standing for extended periods, walking throughout the facility, and performing gowning activities.

Requirements

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related life science field.
• At least 5 years of experience in GMP pharmaceutical microbiology or environmental monitoring, including experience interacting with regulatory agencies.
• Must be authorized to work in the United States on a full-time basis; Lilly will not support or sponsor work authorization or visas for this role.

Nice To Haves

• Experience with aseptic manufacturing or sterile drug product operations, including fill–finish or lyophilization.
• Proficiency with environmental monitoring data systems such as MODA, LabVantage, and Metasys, and quality management systems such as TrackWise and Veeva Vault.
• Hands-on experience with environmental monitoring sampling instruments, including Met One, Climent, Air Ideal, MAS 100, gas sampling equipment, Lighthouse, and PMS systems.
• Working knowledge of microbial identification techniques such as MALDI-TOF, Vitek, and Gram stain, as well as bioburden and endotoxin testing.
• Experience assisting with development of qualification curricula and on-the-job training plans.
• Experience in a greenfield or start-up GMP environment, including cleanroom qualification, authoring SOPs from scratch, equipment selection and qualification, and establishing a quality culture.

Responsibilities

• Own cleanroom and utility monitoring programs, including sampling strategy, risk assessments, alert/action limits, and alignment with the site's contamination control strategy.
• Coordinate shift-based environmental monitoring activities in classified production areas and respond to production needs and environmental concerns.
• Support EMPQs, cleanroom qualifications, utility monitoring readiness, and validation activities.
• Review and approve environmental monitoring and laboratory records, SOPs, and controlled documents, ensuring data integrity and audit readiness.
• Maintain instrument qualification, calibration, maintenance, and method readiness.
• Lead root cause investigations for environmental excursions and manufacturing deviations, partnering with Manufacturing, Quality Assurance, QC, and Facilities, and close CAPAs on time.
• Maintain inspection readiness and present environmental monitoring data during regulatory inspections.
• Train, mentor, and develop environmental monitoring analysts and technicians, promoting aseptic best practices and a Right First Time quality culture.
• Plan staffing and resources to meet production schedules, manage budgets, and drive efficiency and cost improvements.
• Ensure laboratory, cleanroom, and manufacturing support work is performed safely and in compliance with GMP requirements.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal