of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient... based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval...
Job Description General/Position Summary The Director, CMC Inspection Management as part of the Vertex Quality... Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site...
, analytical development, manufacturing science and technology, site QA/QC, and regulatory CMC and commercial functions (i.e., AS&T..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
and associated CMC regulatory considerations in a pharmaceutical environment Proven ability to interact effectively and give...Job Description General Summary: The Director, Analytical Sciences and Technology (Small Molecule Drug Product...
Job Description General Summary: The External Manufacturing Director Cell and Genetic Therapies, role is to oversee.... The External Manufacturing Director of Cell and Genetic Therapies, reports directly to the Senior Director...
, site QA/QC, and regulatory CMC) and commercial functions (i.e., AS&T, MS&T, QC, QA Operations, Supply Chain) to enable..., etc.) are used. Support preparation of CMC clinical and commercial regulatory submissions by critically reviewing and approving...
Job Description General Summary: This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management..., Hemoglobinopathies (Heme) will be responsible for facilitating the cross-functional project teams executing our CMC and manufacturing...
, Technical Operations, Supply Chain and others within Quality Assurance. This position reports to the Associate Director, CMC... alignment with corporate goals and compliance with all regulatory requirements. The role is responsible to provide technical...