of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient... and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies...
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...
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...
, biostatistics, regulatory, safety, CMC, commercial operations. Experience proactively integrates multiple perspectives into the... you to join us! We are currently seeking an Director Clinical Scientist, Immunology Cell Therapy to be based in Boston Seaport. About AstraZeneca...
for new mRNA-based vaccines. As an Associate Director of Physico-Chem Analytics and Separations, you will lead a team... accelerated vaccine CMC development programs. Help design and drive scientific strategy for vaccine early development phases...
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...
Job Description General Summary: The Director, Commercial Operations GMP Quality role for Biologics and Combination... effective and compliant processes and systems to maintain continuous level of regulatory compliance and successful outcome...
we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, External... Manufacturing Solutions to join our team and drive our digital transformation initiatives. The Director, External Manufacturing...
and optimizing digital process control systems, digital manufacturing and CMC solutions. Extensive experience with regulatory... we remain on the forefront of science, medicine and technology. We are seeking a dynamic and experienced Director, Digital...
alignment on scope, timelines, and quality standards. Regulatory Support: Author and review CMC sections for FDA submissions... development activities, and ensuring regulatory-compliant processes suitable for commercial production...
, 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...