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.

Primary Responsibilities:

• 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

Requirements

• 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