Microbiologist, MSAT

• 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.

• 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.
• Knowledge of pharmaceutical aseptic processes and requirements preferred.
• 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

Argenta has strongly embedded company values which is key to who we are and how we deliver.

We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued.

At Argenta we are a hard-working group who really enjoy the people we work with each day.

That is why we support our people through a strong culture, great benefits, and growth opportunities.

Argenta is an equal-opportunity employer

To find out more about Argenta, click here: www.argentaglobal.com