Senior QC Microbiologist

3 days left

Cambridge, Massachusetts, US
May 09, 2021
Jun 26, 2021
Employment Type
Full time
Salary Type

Affinivax is a Cambridge-based clinical stage biotechnology company with a novel, next generation approach to the development of vaccines and immunotherapies targeting infectious and other immune mediated diseases. This novel and highly efficient vaccine technology - called Multiple Antigen Presenting System (MAPS) - enables the high affinity binding of protective polysaccharides as well as proteins in a single vaccine, uniquely inducing a broad and protective B-cell and T-cell immune response.


Affinivax is currently seeking a highly motivated Senior QC Microbiologist I or II to use his/her expertise in microbiology-based assays. This position is ideally suited for someone with hands-on experience in microbiology tests, qualification, validation, and environmental monitoring for clean rooms.

Your Role:
  • Qualification and environmental monitoring for viable and non-viable
  • Sampling and testing of water system for the bioburden, conductivity, and TOC
  • Bioburden and endotoxins testing of raw materials, intermediates, and drug substances
  • Method suitability testing for the bioburden, and endotoxins
  • Raw material sampling and coordinating with contract testing labs
  • Author, review, and approve SOPs, protocols, reports, STM's, technical reports, OOS/OOT/deviation investigations, and change controls
  • Present analytical data and QC microbiology updates to colleagues and senior management
  • Ensure critical reagents, media, ATCC microorganisms, and standards are maintained
  • Prepare QC for the internal and external audits
  • Train team members in environmental monitoring and microbiology tests
  • Additional duties and responsibilities as required

Your Background:
  • Masters or bachelor's degree in Microbiology, Biochemistry, or related discipline with a 5+ years of relevant, hands-on experience
  • Demonstrated experience in performing, qualifying, validating microbiology tests, including TOC and conductivity
  • Experience in GDP, Data Integrity, FDA and EU Guidance, ICH Guidance, USP Monographs and General Chapters
  • Experience with LIMS (BioIT), documentation systems, such as TrackWise, Master Control
  • Hands on experience in using BSC, BioChem Guard, TOC analyzer, conductivity meter. Excellent aseptic technique
  • Good understanding and experience in interpreting microbiology data including sterility test results
  • Previous hands-on experience in performing investigations for the environmental monitoring excursions, OOT and OOS
  • Previous experience in trending environmental monitoring data
  • Strong ability to multi-task and willingness to work effectively in a highly collaborative and diverse environment as a team player with a strong work ethic
  • Ability and desire to work in a fast-paced environment

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