GMP Microbiology Method Development Lead

ARGENTA; Shawnee (KS); On-site; USD 75,000 - 95,000; Full time

Job summary

Argenta is hiring a Microbiologist, MSAT at its Shawnee, KS site. The role leads method development/feasibility, transfer, validation of active ingredients and finished drug product analysis per cGMP and GLP guidelines.

Responsible for ensuring testing aligns with specifications, schedules, and client interfaces with project teams. Requires a biology degree with cGMP/GLP lab background and hands-on experience in sterility, endotoxin, bioburden, ELISA, gram stains, and microbial identifications.

Qualifications

• Bachelor's degree in biology or related science with cGMP/GLP lab experience.
• Minimum 3 years work experience with a BS or 1 year with a master's.
• Proficient in microbiological testing: sterility, endotoxin, bioburden, ELISA, subvisible particulates, identifications.

Responsibilities

• Lead the development and transfer of microbiological methods per cGMP/GLP.
• Analyze in-process, raw materials and finished products for quality and identity.

Skills

Sterility testing

Endotoxin testing

Bioburden testing

ELISA

Gram stains

Microbial identifications

Education

Bachelor's degree in Biology or related Science

Tools

Sterility testing equipment

Endotoxin instrumentation

ELISA instrumentation

Sub-visible particulate instruments

Laminar flow hoods

Autoclaves

Job description

Argenta is hiring a Microbiologist, MSAT at its Shawnee, KS site. The role leads method development/feasibility, transfer, validation of active ingredients and finished drug product analysis per cGMP and GLP guidelines.

Responsible for ensuring testing aligns with specifications, schedules, and client interfaces with project teams. Requires a biology degree with cGMP/GLP lab background and hands-on experience in sterility, endotoxin, bioburden, ELISA, gram stains, and microbial identifications.