Senior GMP Microbiology Scientist, QC & Methods

Scorpion Therapeutics

Indianapolis (IN)

On-site

USD 65,000 - 169,000

Full time

14 days+
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Benefits offered by this job

401(k)
Pension
Vacation
Medical/dental/vision
Life insurance
Time off/leave
Well-being benefits

Job summary

Scorpion Therapeutics seeks a Principal Scientist for GMP QC Microbiology in the Analytical GMP Laboratories. The role oversees sterility, bioburden, microbial limits, and water testing, acting as primary data reviewer for batch disposition.

You will lead method validations, transfers, and verifications, author protocols and change controls, and support equipment qualification. Training junior analysts and ensuring inspection readiness are key parts of the role.

Qualifications

  • BS/MS in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or related.
  • 5+ years in cGMP pharmaceutical microbiology or 3+ years with MS.
  • Authorized to work in the U.S. full-time; Lilly does not sponsor visas.

Responsibilities

  • Perform sterility, bioburden, microbial limits, and water system testing.
  • Lead method validations, transfers, and verifications; author protocols and change controls.
  • Support qualification of lab equipment; evaluate new rapid microbiological methods.
  • Lead OOS/OOT investigations; drive CAPA to closure with QA.
  • Maintain inspection-ready documentation; SME during inspections/audits; update SOPs.
  • Develop/deliver training for junior analysts; maintain training records.

Skills

Aseptic operations
EM data systems
RMM platforms
Microbial identification
Training & mentoring

Education

BS/MS in Microbiology or related field

Tools

MODA/LabVantage/Metasys
TrackWise/Veeva Vault
BacT/ALERT/Milliflex/NAT/PCR
MALDI-TOF/Vitek
LIMS/ELN/QMS

Job description

Scorpion Therapeutics seeks a Principal Scientist for GMP QC Microbiology in the Analytical GMP Laboratories. The role oversees sterility, bioburden, microbial limits, and water testing, acting as primary data reviewer for batch disposition.

You will lead method validations, transfers, and verifications, author protocols and change controls, and support equipment qualification. Training junior analysts and ensuring inspection readiness are key parts of the role.

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