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$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
$187k - $230k
...will report to the Sr. Director Program Management. This role... ...bring late stage clinical development expertise, and... ...functions including research, CMC, non-clinical... ...organization.Prior experience in leading and managing global... ...pharmaceutical or biotech teams is required.Late...SuggestedContract workWork experience placementAfternoon shift2 days per week1 day per week$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...SuggestedRemote 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...
- ...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. 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...
- 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
...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...Full timeH1b$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$190k - $220k
...attempted to protect humankind.*LEAD WITH HEART: Everyone leads at Vaxcyte... ...is seeking an accomplished Associate Director, Immunoassay Development to join the CMC Immunoassay group. This role will... ...for complex conjugated vaccine programs and other vaccine pipeline assets...Contract work$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- Ultragenyx is hiring for a Director, CMC Quality Control - Small Molecules to provide... ...for outsourced testing across development and commercialization. You will lead governance for CMOs/CLs, ensuring... ..., method validation, stability programs, vendor management, and cross-functional...
$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
...Associate Director, Drug Substance Manufacturing – Upstream ProcessBrisbane... ...every day. We lead with empathy, act with... ....Working with the CMC team and other key functions... ...Experience in process development and/or manufacturing... ...of CMC-related programs. Track record of successfully...Flexible 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$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$190k - $280k
...Therapeutics is seeking a Director or Associate Director of Clinical... ...for driving clinical development activities, ensuring... ...in alignment with program goals. Protocol Development... ...Participates in and leads safety and data... ...development within biotech/pharma settings. Expertise...Work at officeFlexible hours2 days per week3 days per week- Genentech in California is seeking a Program Manager to drive drug development programs from Late Stage Research through Proof of Concept. You will guide... ...stakeholders. A life sciences degree with 5-8 years of biotech/pharma experience is required, along with direct...
$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- 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-...
- ...drug substance, product, and finished product stages. You’ll lead the RDQA interface with CMC teams and external partners to preempt risks and drive timely releases. This role requires deep GMP knowledge, program oversight, and strong leadership to coordinate cross‑...
- ...Job Description The Associate Director Regulatory Affairs,... ...Manufacturing and Controls (CMC) works with internal... ...and Research & Development (R&D) organizations. Represents... ...affairs department. Leads initiatives internal... ...our long-term incentive programs. Note: No amount...Full timeLocal area
- ...South San Francisco seeks an Associate Director, Project Management to shape development strategy for neurodegenerative programs and drive disciplined... ...clinical development. You will lead cross-functional teams,... ...collaboration in a fast-paced biotech environment. #J-18808-...
$120.2k - $223.2k
...in the Global Legal Pharma Department.Associate Program Directors of Commercial Medical Legal... ...or cross-portfolio activities and can lead cross-functional CMLRs with oversight... ...strategies and facilitate the timely development and approval of promotional materials...Full timeWork experience placementLocal areaWorldwideRelocation package- ORIC Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across oncology programs. You will collaborate with regulatory, quality, clinical, and manufacturing teams to develop regulatory strategies...
- ...scalable partner enablement framework for its services partner program in San Francisco, California. This role involves designing... ...operations. The ideal candidate has strong skills in content development and collaboration, pivotal for driving effective enablement....
$175k - $210k
Associate Director, Drug Substance Manufacturing - Upstream Process... ...every day. We lead with empathy, act with... ...therapeutics. Working with the CMC team and other key... ...Experience in process development and/or manufacturing... ...management of CMC‑related programs. Track record of...Contract workFor contractorsFor subcontractorWork at officeFlexible hours
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