Oligonucleotide & Small Molecule CMC Analytical Development team while providing hands-on scientific leadership in analytical method... / Core Job Responsibilities: Lead and mentor the Oligonucleotide & Small Molecule CMC Analytical Development team...
with 0+ years of relevant experience;or M.S. degree with 6+ years of industrial experience in biologics CMC development...;or B.S. degree with 8+ years of industrial experience in biologics CMC development. Hands-on laboratory experience...
Practitioner and CMC Physicians. Minimum Qualifications Minimum Education: None. Minimum Years of Experience: None...
of industrial experience in biologics CMC development;or B.S. degree with 8+ years of industrial experience in biologics CMC... in biologics CMC development and technical documentation. Preferred Qualifications: Experience in formulation development...
Job Description General Summary: The Senior Director, CMC Product Leader (T1D) will lead the Chemistry..., Manufacturing, and Controls (CMC) functional team supporting cell therapy products within Biopharmaceutical Sciences - Cell & Gene...
, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership... for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory...
and execute global CMC regulatory strategy and submissions, ensuring the delivery of high-quality CMC dossiers in full compliance... with US & CA regulatory requirements. CMC Regulatory Strategy and submissions for Biologicals: Lead the development and execution of CMC...
, Global Regulatory CMC will support Kite’s autologous CAR T cell therapy portfolio, providing regulatory CMC leadership... for global clinical development and commercial expansion across multiple regions. This role is responsible for CMC regulatory...
of CMC regulatory submission documents of high scientific and technical quality that are compliant with global regulatory... requirements. Implement well-defined, efficient processes for preparation, review and approval of these CMC sections. Plays...
analytical CMC content for INDs, IMPDs, NDAs, amendments, annual reports, briefing documents, and health-authority responses... Analytical Development on CMC program teams and communicate risks, recommendations, timelines, and resource needs to internal...