Principal Microbiologist

Other jobs >> General

Negotiable

Permanent

Description

Overview:

Company Overview



Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success.  With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.



 



People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.



 



The Role



Analytical method development, validation, and transfer activities



API/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testing



Notebook/report review, training, technical writing activities



Implementing, testing, using, or administrating LIMS



To comply & adhere to Good Manufacturing Practice (GMP) standards



Main tasks and responsibilities will include:



Independently perform routine microbiological testing procedures in support of clinical manufacturing (API/raw materials, and drug products) according to SOPs, USP/NF, EP, and JP compendia guidelines, and standard test methods



Environmental Monitoring of manufacturing facility including viable surface sampling, viable air sampling, non-viable air sampling and compressed air testing



Author semi-annual and annual reports for Environmental Monitoring



Evaluate limits and industry expectations for Environmental Monitoring as needed and justify procedure, limits, etc., as required



Document test results in laboratory notebook, in real-time, and communicates status of test results to supervisor



Maintain control of all project related samples submitted to the laboratory



Write and review analytical reports and author technical reports



Communicate with Clients regarding project timelines, data and ongoing studies



Review peer notebooks and analytical reports



Develop and identify training for other personnel



Implement, test, use, or administrate LIMS



Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition



Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA



Comply with all company and site policies and procedures



Manage responsibilities and works in an efficient manner to assure accurate and timely data reports



Order and maintain adequate supply of chemicals and general lab supplies to support microbiological testing



Independently resolve any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy



Additional Responsibilities:



Remain current in profession and industry trends



Make a positive contribution as demonstrated by making suggestions for improvement



Learn new skills, procedures and processes including aspects of formulation development



Is available for other duties as required



Is available for overtime as needed



 



Job Demands



The job may involve the following:



Very high concentration of work



Strict and tight deadlines



Having to juggle a range of tasks/issues simultaneously



Working in a hazardous environment with high requirement to follow safety procedures



Working outside normal working hours



Needing to respond to client demands



 



The Candidate



Requires B.S. in Microbiology, Chemistry, Pharmacy or equivalent with at least 5 years of industrial pharmaceutical microbial laboratory experience



Full knowledge of fundamental microbiology procedures and techniques including aseptic technique, plate count procedures, and organism identification procedures is required



 



Company benefits



In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.



 



  • 1
  • Negotiable
  • None
  • None
  • Re-180884
  • Permanent
  • 3

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