Microbiologist, MSAT

Argenta is currently looking to fill the role of Microbiologist, MSAT at our Shawnee, KS location. This position leads the preparation of protocols and execution of cGMP microbiological method development/feasibility, transfer, verification/suitability, and validation of active ingredient, raw material, cleaning verification, and finished drug product analysis. Position manages multiple concurrent 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. Position will support setup and qualification of new instrumentation and equipment in the laboratory as required.

Responsibilities

Performs and maintains accurate, detailed records for method development/optimization, method transfer/suitability/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 suitability protocols, method validations and reports; Lead the activities to develop microbiological methods to assess the purity, potency, other key attributes, and stability of drug substances and finished products performing testing including sterility, endotoxin, bioburden/microbial limits, ELISA, sub visible particulate, and microbial identifications. Dosage forms including sterile injectables, solid oral dose, soft chews, and non-sterile liquids and pastes; 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 other guidance sources of methodology; Serve as a subject matter expert in advanced laboratory practices by writing SOP’s; 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 biology or related Science field with work experience in cGMP and/or GLP chemistry lab environment (a minimum of 3 years of work experience with B.S. or 1 year of work experience with masters (M.S) is preferred); Proficient at performing microbiological testing techniques including sterility, endotoxin, bioburden/microbial limits, ELISA, sub visible particulate, gram stains, and microbial identifications. Testing of dosage forms including liquid and solid raw materials/API, sterile injectables, solid oral dose, soft chews, and non-sterile liquids and pastes; Proficiency with operating equipment and instruments including sterility testing isolators and decontamination system, endotoxin instrumentation, ELISA instrumentation, sub-visible particulate instrumentation, laminar flow hoods, autoclaves, balances, pH meters, and microbial identification instruments; Ability to effectively manage multiple projects to meet committed scope, cost, and schedule; Strong technical writing to independently author protocols, test methods, procedures, investigations/deviations, and technical papers which may be submitted to regulatory authorities; Knowledge of GMP and FDA manufacturing regulations; Ability to analyze and interpret data; Strong written and oral communication skills

Nice to have

Knowledge of pharmaceutical aseptic processes and requirements preferred

Benefits

strong culture; great benefits; growth opportunities