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
$159k - $207k
...collaboration of leading scientists, industry... ...and managing CMC strategies, deliverables... ...for Denali’s programs, including oversight... ...through all phases of development, including... ...leaders, Program Directors, and cross-functional... ...years of relevant biotech/pharmaceutical/CMO...SuggestedContract workLocal area$190k - $230k
...we create, and our mission's urgency. The Associate Director/Director, Clinical Development Program Management is a senior leadership role... ...This individual works closely with Core Team Leads, Clinical Development, CMC, Regulatory Affairs, Biometrics, Quality, Pharmacovigilance...SuggestedLocal area$159k - $207k
...Organize, manage, and drive CMC strategies, plans, and... ..., manage, and lead internal CMC project teams... ...technical leaders, Program Directors, and cross-functional... ...develop and execute drug development strategies and plans.... ...with 12+ years relevant biotech/pharma/CMO CMC...Suggested$261k - $304.5k
## Senior Director, CMC Lead Product DevelopmentApplylocations: South San... ...opportunity to transform CMC product development into scalable process that... ...strategy for assigned program(s) across the clinical... ...collaborations with other pharma/biotech companies and at the Joint...Suggested- TCG Labs‑Soleil is seeking a Senior Manager / Associate Director, Process Development to lead CMC biologics DS/DP process development and manufacturing efforts. You will oversee technical direction, scale‑up, tech transfer, and cross‑functional collaboration with QA, regulatory...Suggested
- ...in South San Francisco, CA, is seeking a senior CMC lead to organize, manage, and drive CMC strategies for... ...timelines and budgets are integrated into program plans. The role requires a BA/BS with 12+ years in biotech/pharma CMC, advanced degree preferred, GMP experience...
- ...Therapeutics in South San Francisco seeks an Associate Director, CMC Program Management to lead CMC strategies, deliverables, and timelines across development stages, including NDA/MAA submissions... ...The ideal candidate has 12+ years in biotech CMC, proven leadership, and a track...
- AbbVie is seeking an Associate Director Regulatory Affairs, CMC to lead regulatory strategies and submissions for complex products. You will collaborate with R&D, Operations and Global Regulatory teams to enable first-pass approvals and ensure compliant content for INDs...
$170k - $198k
...attempted to protect humankind.*LEAD WITH HEART: Everyone leads... ...Analytical organization as Associate Director, CMC Statistician. The position... ...(JOS) across late-stage development, PPQ, BLA readiness, and commercial... ...statistics experience in biotech/pharma, excellent technical...Remote work$160k - $200k
Senior Manager / Associate Director, Process Development Department: CMC Work Location: This is an on‑site... ...Senior Director, CMC Lead, this individual will help... ...of CMC development programs. This role is ideal for... ...novel “venture capital‑biotech” model. Our core mission...Temporary workFlexible hours- 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...
- ORIC Pharmaceuticals Inc. in South San Francisco is seeking an Associate Director of CMC Program Management to lead end-to-end CMC strategies, cross-functional execution, and external partnerships. You will manage budgets, timelines, and governance with CMOs/CDMOs, ensuring...
- ...a clinical-stage biotech on a confidential... ...for an experienced Program Leader to take ownership... ...individual will lead a cross-functional... ...team, help shape development strategy, navigate... ...Pharmacology, CMC, Commercial or another... ...Senior Director is the anticipated...Full timeRelocation
- ...clinical-stage biopharmaceutical company, seeks an Associate Director of Drug Product Development to lead formulation and process development for small molecules... ...CDMOs, and collaborate with cross-functional CMC teams. You will design phase-appropriate clinical formulations...
- ORIC Pharmaceuticals, Inc. is seeking an Associate Director, CMC Project Management. This role demands a leader to define business processes driving CMC development, ensuring successful execution from development to commercialization. The ideal candidate will have at least...
$210k - $240k
...Associate Director, CMC Project ManagementORIC Pharmaceuticals is a clinical... ...processes that drive complex programs through global registration... ...patients by ensuring that CMC development, manufacturing, and... ...-functional project plans, leading the integrated CMC strategy...H1b- ...Description Job Description Job: Associate Director/Principal Scientist, CMC Analytical Chemistry Location:... ...to clinical analytical development activities and oversee the testing... ...specifications, oversight of stability programs and the active management and documentation...Full timeContract workWork at office
$200k - $215k
...is seeking an experienced Associate Director, Pharmaceutical Development to provide technical and strategic... ...clinical and commercial programs for small molecules. This individual will lead formulation and process... ...Supply Chain and Regulatory CMC to develop scientifically sound...Local area$204k - $281k
About This Role:As the CMC Asset Lead, you will be an integral part of... ...Nephrology team, focusing on the development and launch of Biogen's... ...in matrix leadership across program teams and the full product life... ....Experience in healthcare, biotech, or pharmaceutical industries...Full timeTemporary workLocal area$198k - $257k
...partnerships with leading global... ...global clinical development. Our unique business... ...Function: The Associate Director, Regulatory Affairs... ...activities for assigned programs across regions.... ...Medical Writing, CMC, and other functions... ...of women in biotech. We have achieved...Work at officeWorldwideRelocation package$180k - $210.5k
...protect humankind.*LEAD WITH HEART:... ...global regulatory CMC strategies for investigational... ...into product development. Conducts routine... ...working in vaccine or biotech industry, or in a... ...of projects/programs, with a high degree... ...guidelinesReports to: Executive Director, CMC...$175k - $210k
...together every day. We lead with empathy, act with... ...Position Summary:The Associate Director, Drug Substance Manufacturing... ....Working with the CMC team and other key... ...Experience in process development and/or manufacturing sciences... ...of CMC-related programs. Track record of successfully...Contract workFor contractorsFlexible hours$200k - $220k
...become the industry-leading G protein-coupled receptor... ...small molecule programs with potential for growth... ...are committed to the development of meaningful... ...and highly motivated Associate Director of Process Chemistry... ...operational execution for CMC development and manufacturing...Full timeContract work- ...neuroscience, we are pioneering the development of potential therapies to... ..., a novel portfolio of programs, leading healthcare investors, and... ...teams As an Associate Director, Bioanalytical Sciences you... ...Francisco, right at the heart of Biotech Bay. Our benefits are...Local areaFlexible hoursShift work
- ...San Francisco Bay Area is seeking a Senior/Associate Director-level Program Manager to lead integrated plans for early development programs and manage partnered governance with... ...with Research, Translational Sciences, DMPK, CMC, Clinical Development, Regulatory Affairs,...
$182.47k - $246.87k
...pioneer the world of biotech in our fight against... ...transforming your career. Associate Director - Computational... ...advancing Amgen’s clinical programs and studies by... ...supporting therapeutic development by providing insights... ...CompBio Therapeutic Area Lead and Global Biomarker...Flexible hours- ...YouTube. Job Description The Associate Director Regulatory Affairs,... ...Manufacturing and Controls (CMC) works with internal and external... ..., Operations and Research & Development (R&D) organizations. Represents... ...affairs department. Leads initiatives internal to RA CMC...
- Senti Biosciences seeks a senior regulatory leader to own and drive CMC regulatory strategies for a complex cell therapy portfolio. You... ...with industry standards. Strong leadership, communication, and program management are essential for success in this role. #J-18808-...
- ...seeking an exceptionally talented Program Lead to guide cross-functional development of our clinical and preclinical-stage... ...programs for chronic pain. This Director Level role will drive integrated... ...the spectrum of research, clinical, CMC, regulatory, and finance. This is...
$170k - $200k
...immune diseases and cancer. Our lead program, soquelitinib, is a first-in-... ...system. Reporting to the Director of Analytical Development and Quality Control, the Associate Director of Analytical Development... ...serve as a key member of the CMC team, directing internal...Full timeWork at officeImmediate start
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