Senior Scientist, Analytical Method Development (cGMP)

ARGENTA; Shawnee (KS); On-site; USD 110,000 - 135,000; Full time

Job summary

Argenta is seeking a Senior Scientist, Science & Technology, at the Shawnee, KS site to lead cGMP analytical method development, transfer, verification and validation for API, raw materials and finished drug products. The role requires designing and executing validation plans and managing cross-functional projects.

You will mentor teammates, qualify instruments, ensure detailed documentation, and maintain compliance with GMP/FDA standards.

Qualifications

• Minimum 8+ years with a B.S. or 6+ years with an M.S in cGMP/GLP chemistry lab environment.
• Proficiency in HPLC/GC analysis and preparation of reagents and sample solutions for testing.
• Wet chemistry testing: pH, viscosity, density, particle size testing, titration.
• Experience with mass spectrometry methods and instrumentation preferred.
• Ability to operate laboratory analytical instrumentation and troubleshoot lab equipment.
• Knowledge of GMP and FDA manufacturing regulations.
• Ability to analyze and interpret data.
• Strong written and oral communication skills.

Responsibilities

• Independently manages the design and execution of method transfer and verification protocols, method validations and reports.
• Manages multiple concurrent analytical projects.
• Works with client counterparts and project teams.
• Mentors/leads other analytical development positions in equipment utilization, SOP understanding, and lab practices.
• Sets up and qualifies new instrumentation and equipment in the laboratory.
• Responsible for success of analytical method establishment for new/existing products to site.
• Performs detailed records for method development/optimization, transfer/verification/validation, and routine analysis per cGMP.

Skills

HPLC/GC analysis

Mass spectrometry

Data analysis

Written and verbal communication

Laboratory instrumentation

Education

Bachelor’s degree in chemistry or related Science

Master’s degree preferred

Tools

HPLC/GC systems

Mass spectrometry instrumentation

Job description

Argenta is seeking a Senior Scientist, Science & Technology, at the Shawnee, KS site to lead cGMP analytical method development, transfer, verification and validation for API, raw materials and finished drug products. The role requires designing and executing validation plans and managing cross-functional projects.

You will mentor teammates, qualify instruments, ensure detailed documentation, and maintain compliance with GMP/FDA standards.