Chemist, MSAT

Argenta•Shawnee, KS

1d•Onsite

About The Position

Argenta is currently looking to fill the role of Chemist, MSAT at our Shawnee, KS location. This position is responsible for supporting or leading 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.

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.
Knowledge of GMP and FDA manufacturing regulations
Ability to analyse 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 Haves

a minimum of 2 years of work experience with B.S. or 1 year of work experience with masters (M.S) is preferred.
Experience with mass spec methods and instrumentation preferred.

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 an/d or verification protocols, method validations and reports.
Designs and executes the cleaning validation protocols keeping detailed reports used to assist in writing reports.
Supports or leads the activities to develop analytical methods to assess the purity, potency, other key attributes, and stability of drug substances and finished products.
Responsible in ensuring testing is in adherence to schedules through team-oriented process. Manages effectively own assigned workload and develops timelines for assigned projects to provide to management.
Reads and interprets USP, EP, JP compendial monographs, and analytical methodology.
Serve as a subject matter expert in advanced laboratory practices by writing SOP’s and providing training and guidance to other personnel.
Utilizes root cause analysis tools and technical writing to independently complete laboratory investigations.