The Contamination Control Program Expert will be provide leadership, strategies and guidelines for the client’s Contamination Control Program (CCP) and microbial control strategy initiatives. This role will lead the site contamination control strategy and quality risk management (QRM) initiatives designed to develop a robust microbial control strategy at the site. This role will also lead and/or support investigations related to microbiology. The individual will work closely with stakeholders in manufacturing, quality assurance, engineering, validation, and facilities to drive alignment to site and global contamination control goals and improvement initiatives. This role will also support new product transfers coming to the site related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods
Bachelor’s degree or equivalent experience in Microbiology or Biology or Science and 10+ years of relevant experience in commercial biotechnology or pharmaceutical production managing projects
Working knowledge of microbial risk assessments HACCP/FMEA is desirable
Strong knowledge of cGMPs and applicability to manufacturing operations in a biologics environment is preferred.
Experience in cell and gene therapy and/or Rapid Micro Methods (RMM) is preferred.
Strong knowledge of Lean/Six Sigma and the DMAIC problem solving process is required. Green belt training/certification desired.
Working knowledge of Quality by Design (QbD), Quality Risk Management (QRM), is preferred.
Some Travel May be required
Remote: Contamination Controls Strategy SME (232846)