The Senior Director Regulatory Affairs will work with the Regulatory team in providing strategic leadership and direction in the implementation of strategies, policies, procedures and optimal infrastructure to ensure systems and processes are aligned with company submissions, LFB Corporate and applicable external regulatory authorities. This person/position will work closely with a number of LFB France groups providing guidance and expertise. This person/position must be facile in both CMC and Clinical Regulatory deliverables and will participate in Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).
The Process Engineer III works in the Engineering, Validation & Metrology department and provides expert technical support to Commercial Operations at the Charlton, Framingham and Marlborough facilities. The Process Engineer will provide expertise in troubleshooting problems for manufacturing facilities and metrology functions. The Process Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets LFB-USA. In conjunction with other relevant departments, responsible for providing support for troubleshooting problems in manufacturing, specifies, orders and procures equipment used in manufacturing, performs the preparation of engineering and validation documentation for processes and equipment, initiates the production of batch documentation used for engineering and cGMP production.