- Pharmaceuticals
- Manufacturing
- Medicine
- Chemical Products
- Information Technology & Services
- Technology
- biologics conjugation
- bioprocess cmc
- biosafety
- biologics gmp manufacturing
- biologics discovery service
- cell line development
- formulation development
- analytical characterization
- cell culture and purification process development
- monoclonal antibodies (mabs)
- vaccine development
- vaccine manufacturing
- antibody discovery
- antibody manufacturing
- protein production
- analytical services
- biotherapeutics
- biopharmaceuticals
- and continuous manufacturing
- CEO/President
- Non-Profit Management
- Business Development
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The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. This role develops and executes CMC regulatory strategy, ensures compliance with global requ ...
San Diego2 weeks ago
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The Director, CMC Regulatory Affairs provides strategic leadership and ownership of Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle. · ...
San Diego $165,000 - $205,000 (USD) Full time2 weeks ago
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· Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne m ...
San Diego, CA $130,000 - $210,000 (USD) per year2 hours ago
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Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, · and Controls (CMC) regulatory activities across Capricor's product lifecycle.ResponsibilitiesSupport the development and execution of CMC regulatory strategy... · ...
San Diego $120,000 - $137,500 (USD) Full time2 weeks ago
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This position is responsible for leading tech transfer manufacture release and stability of drug substance/drug product analytical activities to support drug development through late-stage commercialization of our lead compound tinlarebant. · This position also assists in qualifi ...
San Diego2 days ago
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The Manager, CMC Regulatory Affairs is responsible for executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities across Capricor's product lifecycle, · Support the development and execution of CMC regulatory strategy across the product lifecycle (development th ...
San Diego2 weeks ago
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Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease. · ...
San Diego1 month ago
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This position is responsible for leading the tech transfer manufacture release and stability of drug substance drug product and analytical activities to support drug development through late-stage commercialization of our lead compound tinlarebant. · ...
San Diego Metropolitan Area2 days ago
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· Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne m ...
San Diego, CA2 hours ago
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The Director of Regulatory CMC will lead strategic regulatory compliance for assigned commercial products and development projects to ensure timely and efficient preparation and clearance/approval of IND/CTA/MAA/NDA/BLA submissions. · ...
US CA San Diego $187,900 - $256,000 (USD) Full time3 weeks ago
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We are looking for a skilled Regulatory CMC Director to lead our commercial and development projects. · Responsible for regulatory CMC leadership of one or more commercial and development projects. · ...
San Diego $187,900 - $256,000 (USD)3 weeks ago
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Anaptys is an immunology-focused, clinical-stage biotechnology company with a 19-year track-record of discovering life-changing therapeutic antibodies. We have worked to create a work environment where every role has meaning, every team member is respected and every day is a chan ...
San Diego1 month ago
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About Acadia Pharmaceuticals · Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. · ...
San Diego, CA1 month ago
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Reporting directly to the SVP of CMC, the Senior Director of Analytical Sciences will play a critical role in advancing Actio's drug substance and drug product development programs from preclinical through commercial stages.In this highly visible role, you will provide leadership ...
San Diego $257,000 - $280,000 (USD)1 month ago
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We are passionate about creating an inclusive workplace that promotes collaboration, integrity and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures perspectives and experiences to join our team. · Support execution of CMC-related ...
San Diego Metropolitan Area1 month ago
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We are seeking a Regulatory CMC Director to lead the strategic regulatory compliance for assigned commercial products and development projects. The ideal candidate will have extensive experience in regulatory affairs and leadership skills. · ...
US CA San Diego1 week ago
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+Resumen del puesto · The Associate Director serves as a key interface between CMC Quality Supply Chain Finance Procurement. · ...
San Diego $156,000 - $195,000 (USD)1 month ago
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We are seeking an experienced Senior Director of Analytical Sciences to play a critical role in advancing our drug substance and drug product development programs. · ...
San Diego, CA1 month ago
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This is an exciting time to join Crinetics as we shape our organization into the world's premier fully integrated endocrine company from discovery to patients. · ...
San Diego $156,000 - $195,000 (USD) Full time1 month ago
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+ Job summary · The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of clinical supply management and strategy, global regulatory requirements, and project management practices. + · + ResponsibilitiesManaging ...
San Diego1 month ago
Vice President, Commercial CMC - San Diego - confidential
Description
Is this the role you are looking for If so read on for more details, and make sure to apply today.
Vice President, Commercial CMC
About the Company
Industry leading open-access biologics technology platform
Industry
Pharmaceuticals
Type
Public Company
Founded
2015
Employees
10,001+
Categories
Specialties
About the Role
The Company is seeking an Executive Director or Vice President for North America Commercial CMC. This leadership role is pivotal in overseeing the strategic and operational aspects of CMC, ensuring the successful commercial development, validation, and commercialization of large molecules while maintaining regulatory compliance and industry standards. The successful candidate will be responsible for leading and developing commercial CMC teams, driving business strategies, and managing client relationships. A strong background in CMO and external contract manufacturing, as well as experience in late-stage and commercial development of biologics, is essential. The role also involves cross-functional collaboration, continuous improvement, and staying abreast of industry trends to guide decision-making.
Candidates for this position should have a degree in a relevant scientific discipline, with a PhD strongly preferred, and at least 15 years' experience in large pharma and CMOs. Technical proficiency in CMC development and manufacturing, regulatory expertise, and a proven track record in managing large molecules, supply chain, and contractor management are required. The ideal candidate will have a strategic mindset, be adept at problem-solving, and have a history of delivering results in a fast-paced environment. xhmxlyz Leadership skills, including the ability to inspire a culture of collaboration and high performance, and excellent communication and interpersonal skills are also key qualifications for this role.
Hiring Manager Title
SVP, Head of Global CMC
Travel Percent
Less than 10%
Functions
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Director, CMC Regulatory Affairs
Only for registered members San Diego
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Director, CMC Regulatory Affairs
Full time Only for registered members San Diego
-
Director, CMC Regulatory Affairs
Only for registered members San Diego, CA
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Manager, CMC Regulatory Affairs
Full time Only for registered members San Diego
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Associate Director, CMC
Only for registered members San Diego
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Manager, CMC Regulatory Affairs
Only for registered members San Diego
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Regulatory Affairs CMC Associate
Only for registered members San Diego
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Associate Director, CMC
Only for registered members San Diego Metropolitan Area
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Manager, CMC Regulatory Affairs
Only for registered members San Diego, CA
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Director, Regulatory CMC
Full time Only for registered members US CA San Diego
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Director, Regulatory CMC
Only for registered members San Diego
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Senior Vice President, CMC
Only for registered members San Diego
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Associate Director, Regulatory Affairs CMC
Only for registered members San Diego, CA
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Sr Director, Analytical Sciences
Only for registered members San Diego
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Associate Director, CMC Operations
Only for registered members San Diego Metropolitan Area
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Director, Regulatory CMC
Only for registered members US CA San Diego
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Associate Director, Outsourcing
Only for registered members San Diego
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Sr Director, Analytical Sciences
Only for registered members San Diego, CA
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Associate Director, Outsourcing
Full time Only for registered members San Diego
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Director, Global Supply Chain
Only for registered members San Diego