Microbiologist

New Haven, Connecticut, United States | Full-time

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Overview

Invicro does contract research focusing on the development of short half life radiotracers for PET and SPECT imaging. Due to the nature of product being manufactured at Invicro, aseptic processes and environmental control are essential to ensure safety of our products. We are seeking a motivated and dynamic microbiologist who can adapt to the fast speed environment and bring pre-existing experience to perform environmental monitoring of an atypical GMP environment.

The key responsibilities of the microbiologist are to provide support and expertise in the sterility testing of radiotracers, as well as performing environmental monitoring of the laboratories, to ensure compliance to relevant standards involved in the production and aseptic manipulations of sterile products manufactured within Invicro.

                                                                                           

Responsibilities: 

  • Monitoring sterility testing of radiotracers and manage contractor companies for outsourced microbiological testing.
  • Monitoring and trending of microbiological data.
  • Documenting microbiological records to ensure compliance with cGMP.
  • Regularly reporting of results and summaries of own work to line manager.
  • Responsible for microbiological test implementation at Invicro: method development, validation and documentation.
  • Investigations of MOOS results obtained from microbiological testing
  • To keep procedural documents and policies on Environmental Monitoring relevant and up to date with Regulation guidelines.
  • To lead site compliance and remedial activities in microbiologically related areas
  • To help Invicro continue to look to improve sterile process assurance.
  • Will be expected to train and educate others in his/her area of expertise.
  • Perform other duties as assigned.

 

Qualifications and Skills:                                      

  • Bachelor’s level degree in microbiology or proven 3-5 years experience in relevant field.
  • Adaptability to a fast speed work environment, due to the short half life of the radioactive isotopes.
  • Good knowledge of cGMP and USP
  • Detail oriented and good analytical thinking
  • Ability to understand oral and written communications and ability to express results accurately and promptly

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.