Senior Scientist, Science & Technology

Argenta is currently looking to fill the role of Senior Scientist, Science & Technology at our Shawnee, KS location. This position leads the preparation of protocols and execution of cGMP analytical method development, transfer, verification, and validation of active ingredient, raw material, cleaning verification, and finished drug product analysis.

Responsibilities

Leads the preparation of protocols and execution of cGMP analytical method development, transfer, verification, and validation of active ingredient, raw material, cleaning verification, and finished drug product analysis; Independently manages the design and execution of method transfer and/or verification protocols, method validations and reports; Manages multiple concurrent analytical projects; Works with client counterparts and project teams; Serves as a mentor/lead to other analytical development positions in such areas as equipment utilization, SOP understanding and application, and good lab documentation and lab practices; Setup and qualification of new instrumentation and equipment in the laboratory as required; Responsible and accountable for the success of analytical method establishment for new and/or existing products to the site; Performs and maintains accurate, detailed records for method development/optimization, method transfer/verification/validation, and for routine analysis of finished pharmaceutical dosages and/or raw materials following approved analytical methodology and specifications to pharmaceutical cGMP requirements; Designs and executes the cleaning validation protocols keeping detailed reports used to assist in writing reports

Requirements

Bachelor’s degree in chemistry or related Science field with work experience in cGMP and/or GLP chemistry lab environment (a minimum of 8+ years of work experience with B.S. or 6+ years of work experience with masters (M.S) is preferred); Proficient at HPLC/GC analysis and preparation of reagents and sample solutions for testing; Proficiency with wet chemistry testing methodologies and techniques such as pH, viscosity, density, particle size testing, titration; Demonstrated ability to operate laboratory analytical instrumentation and be able to assist in the troubleshooting and calibration of laboratory equipment; Knowledge of GMP and FDA manufacturing regulations; Ability to analyze and interpret data; Strong written and oral communication skills

Nice to have

Experience with mass spec methods and instrumentation

Benefits

strong culture; great benefits; growth opportunities