Principal Microbiologist

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.