The Medical Director will support development and execution of the clinical strategy for assigned programs at LFB USA in order to meet company objectives. The Medical Director is a resource internally and externally on all medical and clinical topics. He/she will work closely with clinical and regulatory teams at LFB globally and serves as a key strategic and medical point person during the conduct of trials and in the presentation of clinical data. Will provide medical support in conjunction with health authority meetings (FDA/EMA/other).
Responsible for supporting the QC function in terms of method validation, transfer of analytical processes to CMOs, writing and reviewing protocols, change controls and SOPs, and assisting with testing for stability, in process and release of samples.
The Process Engineer II 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 with manufacturing and facilities. The Process Engineer will be responsible for the lifecycle management of various commissioning, qualification, and/or validation facets of 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 validation documentation for processes and equipment, initiates the production of batch documentation used for engineering and cGMP production.
The Director of External QA will develop and provide strategic direction in the implementation of quality strategies, policies, procedures and optimal infrastructures to ensure all external CMOs/CTLs are in compliance with all regulatory agencies, i.e., FDA, EMA, etc. This position is primarily responsible for all quality assurance aspects relating to quality oversight of drug substance and drug product manufacturing, including packaging/labeling and testing programs and requires a wide range of skills across the quality function to allow for flexibility as the goals and objectives shift to fit the organization's needs.