Senior Chemist, MSAT

Argenta is currently looking to fill the role of Senior Chemist, MSAT 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. Position manages multiple concurrent analytical projects and has client interface responsibility with client counterparts and project teams. The position requires analyzing in-process, raw materials and finished product of pharmaceuticals for quality, safety, purity, strength and identity by conducting analysis as specified in the applicable specification requirements following GLP and cGMP guidelines. 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. Position has training responsibility for the department once qualified and will have data review responsibility. Position will lead setup and qualification of new instrumentation and equipment in the laboratory as required. Position is responsible and accountable for the success of analytical method establishment for new and/or existing products to the site.

Responsibilities

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; Independently manages the design and execution of method transfer and/or verification protocols, method validations and reports; Designs and executes cleaning validation protocols keeping detailed reports used to assist in writing reports; Leads the activities to develop analytical methods to assess the purity, potency, other key attributes, and stability of drug substances and finished products; Ensures testing is in adherence to schedules through team-oriented process, manages effectively own assigned workload and develops timelines for assigned projects; Serves as backup and delegate for laboratory manager; Reads and interprets USP, EP, JP compendial monographs, and analytical methodology; Serves as subject matter expert in advanced laboratory practices by writing SOPs and providing training and guidance to other personnel; Utilizes root cause analysis tools and technical writing to independently complete laboratory investigations; Provides technical subject matter expert input and addresses work performed on project calls both with internal project teams and to external clients

Requirements

Bachelor’s degree in chemistry or related Science field with work experience in cGMP and/or GLP chemistry lab environment; Proficient at HPLC and 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 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; Demonstrated knowledge & awareness of current industry issues & evolving trends in the regulated environment; both domestically & internationally

Nice to have

Master's degree (M.S.); Experience with mass spec methods and instrumentation

Benefits

Strong culture; great benefits; growth opportunities