CMC Program Lead (Associate Director) - Biotech Development
Denali Therapeutics Inc
Denali Therapeutics Inc is seeking a leader to organize and manage CMC strategies, deliverables, and timelines for programs, including oversight of CRO/CMO activities from research through NDA/MAA and commercial phases. The role requires coordinating with technical leaders, program directors, and cross-functional teams to integrate CMC deliverables into project timelines. Qualifications include a BA/BS in a scientific field with 12+ years of biotech/pharmaceutical CMC experience (or Master’s #J-18808-Ljbffr Denali Therapeutics Inc
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...multiple) for the position of Associate Director, Chemical Development based out of its location... ...of ongoing clinical programs. Delivery of robust, scalable... ...consistency of DS quality. Lead the characterization of... ...commercialization. Prepare and/or review CMC sections of INDs, CTAs,...Contract work- A leading biotech firm in South San Francisco seeks an Associate Director / Director, Analytical Lead to manage analytical characterization efforts within Protein Sciences. The ideal candidate will have 12+ years of experience in antibody characterization and a Ph.D. in...
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...processes that drive complex programs through global... ...by ensuring that CMC development, manufacturing, and commercialization... ...reports to Senior Director, CMC Program... ...project plans, leading the integrated CMC strategy... ...salary range for Associate Director level candidates...H1b$180k - $241k
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...Associate Director/Director, Clinical Science Lycia Therapeutics... ...for driving clinical development activities, ensuring... ...in alignment with program goals Clinical... ...Participates in and leads safety and data cleaning... ...development within biotech/pharma settings Expertise...Full timeWork at officeFlexible hours2 days per week3 days per week$198k - $257k
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