Aerogen Pharma Career Opportunities
Senior Director of Quality
Department: Pharmaceutical
Location: USA
The Senior Director of Quality Assurance is responsible for development and maintaining of quality business strategy and quality management system compliant with FDA drugs, biologics and combination products, with awareness of ISO 13485. This person will establish cross-functional roles and responsibilities and have accountability for execution of all strategic imperatives. The role will lead an internal QA organization of 3 - 4 individuals and strategic consultants. Sr Director of Quality will direct the development, implementation and maintenance of quality assurance systems and activities. Will provide the signatory authorization from Quality for control documentation and final product disposition. Will be responsible for the investigations and resolution of product quality and compliance issues seen at approved service providers. Will have oversight of clinical quality assurance (GCP). This position is a hybrid role, located in Morrisville, NC office and is a key member of the leadership team that contributes and supports the company’s research and development programs. This position will report to the Aerogen Pharma CEO.
Senior Scientist, Product Development
Department: Pharmaceutical
Location: California, USA
The person in this role will be responsible for key aspects of pharmaceutical development of AeroFact. A key role will be the regulatory authoring and creating a robust BLA submission. The role will focus on late stage product development of Aerofact and the biologic / device combination product, inclusive of the data and studies associated with the development or optimization of analytical methods, product characterization of a lipid-peptide formulation, aerosol characterization of the combination product, and management of drug substance/drug product stability studies supporting clinical and BLA registration.