Senior QC Microbiologist
- Employer
- Affinivax
- Location
- Cambridge, Massachusetts, US
- Salary
- Competitive
- Closing date
- Jul 14, 2021
View more
- Sector
- Consultancy/Private Sector
- Field
- Conservation science
- Discipline
- Other
- Salary Type
- Salary
- Employment Type
- Full time
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Overview:
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.
Summary:
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:
Your Background:
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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.
Summary:
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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