Lead GMP QC Microbiology Scientist & Validation

BioSpace; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) matching

Pension

Medical, dental, vision

Vacation benefits

Well-being benefits

Job summary

Lilly is seeking a Principal Scientist, GMP QC Microbiology to support the Medicine Foundry in Carmel/Independence, IN. You will lead sterility, bioburden, endotoxin and other microbiology testing, mentor analysts, and contribute to method validation and regulatory readiness.

Role requires cGMP microbiology experience, collaboration with QA, Manufacturing, and Regulatory Affairs, and commitment to data integrity and continuous improvement in a cutting-edge facility.

Qualifications

• BS or MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related technical discipline.
• 5+ years (BS) or 3+ years (MS) of cGMP pharmaceutical microbiology experience, including compendial method execution and investigations.
• Authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization.
• Experience with aseptic manufacturing or sterile drug product operations is preferred.

Responsibilities

• Perform sterility, bioburden, microbial limits, and water system testing; primary data reviewer for batch disposition.
• Lead method validations, transfers, verifications; prepare protocols and change controls; support equipment qualification.
• Lead OOS/OOT investigations and drive CAPA to closure with QA.
• Maintain inspection readiness; act as SME during inspections and audits; update SOPs as needed.
• Develop and deliver training for junior analysts on test methods and aseptic technique.

Skills

GMP microbiology

Bioburden testing

Sterility testing

Water testing

Microbial identification

Method validation

CAPA management

Regulatory audits

Training junior analysts

Education

BS Microbiology

MS Microbiology

CGMP experience

Tools

MODA

LabVantage

Metasys

TrackWise

Veeva Vault

Job description

Lilly is seeking a Principal Scientist, GMP QC Microbiology to support the Medicine Foundry in Carmel/Independence, IN. You will lead sterility, bioburden, endotoxin and other microbiology testing, mentor analysts, and contribute to method validation and regulatory readiness.

Role requires cGMP microbiology experience, collaboration with QA, Manufacturing, and Regulatory Affairs, and commitment to data integrity and continuous improvement in a cutting-edge facility.