Quality Control Senior Associate / Supervisor: Microbiology and Environmental Monitoring
Great opportunity to be part of a dedicated team building capability to serve the rapidly expanding gene therapy market. Vector Biomed aims to become a leading supplier of high quality Lentiviral vectors for research and clinical use. Team members will support cGMP manufacturing in a dynamic new company setting. We are seeking a person experienced in EM practices to build and oversee this critical manufacturing support activity. Job title commensurate with experience.
- Establish process and documentation for EM monitoring program to support cGMP manufacturing (MFG) operations
- Support set-up of lab operations (equipment order and installation & qualification, new SOP’s, etc)
- Train support staff as needed to provide routine EM
- Support execution of EM-PQ
- Serve as liaison between MFG and contract cleaning services to monitor cleaning service effectiveness, adapt to MFG schedule, etc.
- Establish systems to collect, analyze and report routine EM data
- Establish and execute select microbio-based QC assays (e.g. bioburden)
- Adhere to quality standards for job training and ensure GMP compliance
- BS and a minimum of 3 yrs relevant experience in a microbiology / environmental monitoring role.
- Sufficient knowledge and expertise in environmental monitoring to lead development of a new program.
- Knowledge of cGMP requirements and good documentation practices
- Self-starter with demonstrated leadership ability