Director, CMC Regulatory Affairs

Found in: beBee jobs US - 2 weeks ago

Waltham, Massachusetts, United States Tscanrx Full time

We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology cell therapy products, from preclinical to eventual commercial stages.The ideal candidate should have relevant experience in CMC regulatory activities for investigation cell therapy products in oncology, and enjoy fast-paced, collaborative and vibrant startup culture.Develop and execute global CMC regulatory strategies for oncology cell therapy products in alignment with the company's objectives and regulatory requirementsProvide CMC regulatory expertise and input to cross-functional teams, such as manufacturing, quality, research, and clinical development, to ensure alignment and compliance with CMC regulatory requirementsMinimum of 10 years of experience in CMC regulatory affairs in the biotechnology or pharmaceutical industry, with at least 5 years in a leadership roleExperience in developing and implementing global CMC regulatory strategies for cell therapy or gene therapy products is highly preferredExperience in preparing and submitting CMC sections of INDs, BLAs, and amendments for cell therapy or gene therapy products is required

  • Manager/Senior Manager, CMC Regulatory Affairs

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Great Science.Deep Compassion.Real Impact.Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio...

  • Director, Regulatory Affairs

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, Regulatory Operations

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, Supply Chain Planning

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Executive Director, Medical Director

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, MSAT, BaseCamp Waltham

    Found in: beBee jobs US - 3 days ago

    Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...

  • Associate Director, Clinical Scientist

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Assistant Director, Community Living

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Brandeis University Full time

    Brandeis University is delighted to announce a career opportunity as the Assistant Director of Community Living in Student Affairs. At Brandeis, we offer a competitive benefits and compensation package which includes medical, dental and life insurances. If you are looking to advance your career through educational opportunities, Brandeis offers tuition...

  • Manager, Medical Information

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    The Manager, Medical Information will assist in the operational oversight of Medical Information within the Medical Affairs function. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. This...

  • Director, Clinical Quality Assurance

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Director, Clinical Pharmacology

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, Statistical Programming

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • SVP, Head of Data Analytics

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • SVP, Head of Data Analytics

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Director of Revenue Operations

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Allego Full time

    The Senior Director of Revenue Operations at Allego is responsible for ensuring the smooth and efficient functioning of the Sales and Marketing teams through effective processes, tools, and analytics. This role involves leadership, coordination, and management of various support functions including reporting, budgeting, forecasting, and systems development....

  • Senior Director, Translational Biomarkers

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • VP, Global Market Access

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Associate Director, HR Operations

    Found in: beBee jobs US - 3 days ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Director, Drug Safety and Pharmacovigilance

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Manager, General Counsel Operations

    Found in: beBee jobs US - 1 week ago

    Waltham, Massachusetts, United States National Grid Full time

    About usNational Grid is hiring a Manager of General Counsel Operations. This role may be located in Brooklyn, NY; Syracuse, NY; Hicksville, NY; or Waltham, MA. Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they live. The...