Director, Pathogen Safety

Job description

The position will be accountable for establishing the Pathogens Safety (PS) strategies for the project portfolio of respective Integrated Product Teams (IPTs) such as Plasma-Derived Medicinal Products, Vaccines, Recombinants and ensuring that the pathogen safety data packages are executed in partnership with PS Laboratories and PS Support teams. You’ll be seen as a strategic thinker, a leader and influencer within Pathogen Safety and beyond. You will also be responsible for maintaining awareness of external trends such as emerging industry and regulatory best practice. RESPONSIBILITIES AND ACCOUNTABILITIES: · Leads the development and execution of all aspects of Pathogen Safety strategy for respective product platform including requirements for starting and raw materials, virus and prion testing strategy definition, pathogen reduction footprint over manufacturing process and adventitious agents’ contamination control strategies for manufacturing facilities. · Accountable for delivery of end-to-end overall safety strategies for all projects under respective IPT portfolio from defining pathogen safety measures to providing high quality packages to the regulatory authorities whilst ad...