Senior Scientist, cGMP Analytical Methods & Validation

Argenta; Shawnee (KS); On-site; USD 110,000 - 140,000; Full time

Job summary

Argenta in Shawnee, KS seeks a Senior Scientist, Science & Technology to lead cGMP analytical method development, transfer, verification, and validation for active ingredients, raw materials, cleaning verification, and finished drug products.

The role requires 8+ years in a regulated chemistry lab, expertise in HPLC/GC and MS, wet chemistry, and strong data interpretation with good communication skills.

Qualifications

• Bachelor’s degree in chemistry or related field with 8+ years in cGMP/GLP lab environment (preferred: 6+ years with a master’s).
• Proficient at HPLC/GC analysis and preparation of reagents and samples for testing.
• Proficiency with wet chemistry testing: pH, viscosity, density, particle size, titration.
• Experience with mass spectrometry methods and instrumentation preferred.
• Ability to operate laboratory analytical instrumentation and assist in troubleshooting and calibration.
• Knowledge of GMP and FDA manufacturing regulations.
• Ability to analyze and interpret data.
• Strong written and oral communication skills.

Responsibilities

• Independently designs and executes method transfer/verification protocols, method validations and reports.
• Manages multiple concurrent analytical projects.
• Collaborates with client counterparts and project teams.
• Mentors analytical development staff in equipment use, SOPs, and good lab documentation.
• Sets up and qualifies new instrumentation in the lab as required.
• Ensures success of analytical method establishment for products at the site.
• Maintains detailed records for method development/verification, and routine analysis.
• Designs and executes cleaning validation protocols and prepares reports.

Skills

HPLC/GC analysis

Mass spectrometry

Wet chemistry testing

Data analysis

Instrumentation calibration

Regulatory knowledge

Written and verbal communication

Education

Bachelor’s degree in chemistry

Master’s degree in chemistry

Tools

Mass spectrometry equipment

Analytical instrumentation

Job description

Argenta in Shawnee, KS seeks a Senior Scientist, Science & Technology to lead cGMP analytical method development, transfer, verification, and validation for active ingredients, raw materials, cleaning verification, and finished drug products.

The role requires 8+ years in a regulated chemistry lab, expertise in HPLC/GC and MS, wet chemistry, and strong data interpretation with good communication skills.