Senior Chemist, MSAT

Argenta•Shawnee, KS

17h•Onsite

About The Position

Argenta is seeking a Senior Chemist, MSAT for their Shawnee, KS location. This role is responsible for leading the preparation of protocols and execution of cGMP analytical method development, transfer, verification, and validation for active ingredients, raw materials, cleaning verification, and finished drug products. The position involves managing multiple analytical projects concurrently and interacting with clients. Key responsibilities include analyzing in-process, raw materials, and finished pharmaceutical products to ensure quality, safety, purity, strength, and identity according to GLP and cGMP guidelines. The role also includes mentoring other analytical development staff, training department personnel, reviewing data, and leading the setup and qualification of new laboratory instrumentation. The Senior Chemist is accountable for the successful establishment of analytical methods for new and existing products.

Requirements

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

Nice To Haves

A minimum of 6 years of work experience with B.S. or 3 years 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 and/or verification protocols, method validations and reports.
Designs and execute the cleaning validation protocols keeping detailed reports used to assist in writing reports.
Lead 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.
Serves as backup and delegate for laboratory manager.
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.
Provides technical subject matter expert input and addresses work performed on project calls both with internal project teams and to external clients.
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.
Manages multiple concurrent analytical projects and has client interface responsibility with client counterparts and project teams.
Analyzes 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.
Has training responsibility for the department once qualified and will have data review responsibility.
Leads setup and qualification of new instrumentation and equipment in the laboratory as required.
Is responsible and accountable for the success of analytical method establishment for new and/or existing products to the site.