- Adverum Biotechnologies (Redwood City, CA)
- The Director / Sr Regulatory Affairs will lead the overall CMC Regulatory strategy for Adverum's gene therapy program/s. This individual will be the key ... interface between the Regulatory and CMC functions, partner with Process Development , Manufacturing,...and Quality; and assist in ensuring regulatory compliance. The Director / Sr will be responsible for developing, executing,… more
- Nova Anchora (Boston, MA)
- …academic development into the clinic, we are seeking a highly skilled and experienced Senior Director of CMC to lead this critical phase of our journey. ... The Senior Director of CMC will...The Senior Director of CMC will play a pivotal... strategies and execution plans that effectively achieve phase-appropriate CMC development goals, initially focusing on Phase… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- The opportunity Vir Biotechnology is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring all ... assigned products have a successful regulatory CMC strategy for clinical development and commercialization. You should bring both a track record of successful… more
- San Francisco (San Francisco, CA)
- …THE ROLE Reporting to the Vice President, CMC Operations, the Head of/ Senior Director CMC Operations (Drug Substance) will manage activities related ... equivalent years of experience. 20+ years of industry experience in CMC process development , IPC testing, and manufacture. Solid working knowledge of various… more
- Indapta Therapeutics Inc. (San Francisco, CA)
- …The Position: Indapta seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer the autonomy, excitement, ... moving from early to later phase clinical trials. Responsibilities will include: Lead the CMC QA function and partner with clinical, regulatory and CMC teams,… more
- Astria Therapeutics Inc (Boston, MA)
- …and being explored for other allergic and immunological diseases. The VP/ Sr . Director , Program Leader oversees one or more development programs in Astria's ... diverse R&D activities including but not limited to, preclinical research, clinical development , CMC , regulatory affairs, new product planning, business … more
- BridgeBio Pharma (San Francisco, CA)
- Director / Sr . Director , Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics, an affiliate of BridgeBio Pharma, ... Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic… more
- IGM Biosciences, Inc. (Mountain View, CA)
- …inflammation targets. For more information, please visit www.igmbio.com.Position SummaryAs Director , Clinical Supply Planning and Project Management, you will lead ... to plan and deliver on-time, compliant clinical supply per the clinical development plan.Develop and lead aC&OP process that integrates clinical supply and demand… more
- Atlas Venture (Boston, MA)
- Senior Director , Drug Product Development ...compounds for in vivo studies.As a part of the CMC development team, evaluate and select the most ... activities and manufacture.Key aspects of the role are:Key member of Project Development Teams, collaborate and partner closely with CMC project management,… more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …Clinical Operations, Regulatory Affairs, and Quality Assurance. This position reports to the Senior Director , Supply Chain Systems and will be in Boston, MA, ... , corporate, and commercial operations. About the Role: We are seeking a Senior Manager/Associate Director , Supply Chain Planning to join our team. The… more
- Dennis Partners (Boston, MA)
- …therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on ... of EU and international regulations related to the clinical, nonclinical, and CMC development a plus.Must have experience preparing for and participating… more
- Vertex Pharmaceuticals (Boston, MA)
- …General Summary: This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Povetacicept (POVE) will be responsible for facilitating ... the cross-functional project teams executing our CMC and manufacturing strategies within Vertex's newly formed POVE portfolio. Povetacicept is a Phase 3 ready asset… more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- Job DescriptionGeneral Summary:This Commercial Manufacturing and Supply Chain (CMSC) Director Project Management, Povetacicept (POVE) will be responsible for ... facilitating the cross-functional project teams executing our CMC and manufacturing strategies within Vertex's newly formed POVE portfolio. Povetacicept is a Phase 3… more
- Ascendis Pharma A/S (Palo Alto, CA)
- …core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class ... a dynamic workplace for employees to grow and develop their skills.The Director , Regulatory Affairs will be responsible for developing and implementing global… more
- Antares Pharma (San Diego, CA)
- Associate Director , External Quality AssuranceWelcome to an inspired career.At Halozyme, we are reinventing the patient experience and building the future of drug ... our mission and making our One Team culture thrive.Join us as an Associate Director , External Quality Assurance and you'll be part of a culture that welcomes… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will ... CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing...budget, and resource allocation, and provide regular updates to senior management. + Lead other tasks / projects as… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development , located at either our Boston or South ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...small molecule pipeline. Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is ... operate" by maintaining the global licensures. In addition, the Sr Director will be accountable for leading...and Skills** + Lead the execution and influence the development of global CMC regulatory strategies, including… more
- Lilly (Indianapolis, IN)
- …solutions to support communities through philanthropy and volunteerism. **Position Summary:** The Senior Director , CMC Project Management will provide ... therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams. + Lead… more
