VP, Technical Operations and CMC

4 weeks ago

New York, United States Barrington James Full time

VP, Technical Operations and CMC


One of our key clients, a dynamic and rapidly expanding late-stage gene therapy company, is currently seeking a VP of Technical Operations and CMC. This is an exceptional opportunity to join a company in the late-stage development of their gene therapy indication, where you will play a pivotal role in helping them prepare for launch and commercialization. They are seeking a highly experienced and driven VP of CMC and Technical Operations to lead critical initiatives across their CMC and manufacturing functions, reporting directly to their Chief Technical Officer.


Main Responsibilities:


  • Develop and implement strategic plans for product development, analytical development, and manufacturing to support the company's growing gene therapy pipeline. Align departmental goals with overall company objectives and regulatory requirements in collaboration with executive leadership.
  • Lead the transfer of analytical methods and processes to both internal and external Quality Control and manufacturing teams. Ensure seamless integration with development projects and mitigate CMC risks throughout the product lifecycle.
  • Oversee and integrate cross-functional development projects, ensuring effective collaboration across departments. Support the manufacture and testing of clinical and commercial launch supplies.
  • Oversee the development and optimization of gene therapy vectors, formulations, and delivery methods. Ensure robust process development, scale-up, and validation of manufacturing processes in compliance with regulatory guidelines and quality standards.
  • Author and review CMC sections of regulatory submissions (BLA, IND, etc.) and work closely with Regulatory Affairs to ensure the timely and accurate submission of documents. Lead CMC activities for regulatory submissions and launch activities.
  • Ensure timely characterization of gene therapy products, including potency, purity, and stability testing. Ensure all CMC and manufacturing activities comply with FDA, EMA, and other global regulatory agency requirements.
  • Develop and maintain strong relationships with Contract Development and Manufacturing Organizations (CDMOs) and other external partners to ensure the successful execution of development and manufacturing activities.


Qualifications:


  • Must have a PhD in a relevant field.
  • Over 15 years of relevant experience in CMC and technical operations.
  • Experience in leading Analytical and Process Development teams, with hands-on experience also preferred.
  • Direct experience in gene therapy development is highly desirable.
  • Proven experience as the CMC lead for BLA submissions and successful launch activities.
  • Strong understanding of regulatory guidelines and quality standards, including FDA, EMA, and global regulatory requirements.
  • Demonstrated leadership and collaboration skills, with the ability to work cross-functionally and drive projects to completion.


Apply today to learn more or drop me an email to rbanton@barringtonjames.com

  • Vice President of Technical Operations and CMC

    1 month ago

    New York, New York, United States Barrington James Full time

    VP, Technical Operations and CMCBarrington James is seeking a highly experienced and driven VP of Technical Operations and CMC to lead critical initiatives across their CMC and manufacturing functions. This is an exceptional opportunity to join a company in the late-stage development of their gene therapy indication, where you will play a pivotal role in...

  • Regulatory CMC Specialist

    1 week ago

    New York, New York, United States Katalyst HealthCares & Life Sciences Full time

    Job Summary: We are seeking a highly skilled Regulatory CMC Manager to join our team at Katalyst HealthCares & Life Sciences. The successful candidate will be responsible for the development of Chemistry, Manufacturing and Control (CMC) documentation for commercial products within our portfolio. Key Responsibilities:Support the CMC Documentation Team in the...

  • Regulatory CMC Specialist

    2 weeks ago

    New York, New York, United States Katalyst HealthCares & Life Sciences Full time

    Job Title: Regulatory CMC ManagerAt Katalyst HealthCares & Life Sciences, we are seeking a highly skilled Regulatory CMC Manager to join our team. The successful candidate will be responsible for preparing technical CMC registration documents to maintain existing marketing authorizations in various countries.Key Responsibilities:Support the CMC Documentation...

  • VP, Technical Services

    4 weeks ago

    New York, New York, United States Jones Lang LaSalle Full time

    Job SummaryJones Lang LaSalle is seeking a highly skilled and experienced VP, Technical Services to join our team. As a key member of our organization, you will be responsible for leading and managing the technical services department, ensuring that all operations are aligned with our mission and values.Key ResponsibilitiesManage and oversee technical...

  • Senior Director, Radiopharmaceuticals CMC

    4 weeks ago

    New York, New York, United States Kennedy Bond Full time

    Senior Director, Radiopharmaceuticals CMCKennedy Bond is seeking a highly experienced Senior Director to lead our Radiopharmaceuticals CMC team. As a key member of our organization, you will be responsible for developing and implementing process development and CMC strategies for radiopharmaceutical drug candidates.Main Responsibilities:Process Development:...

  • VP of Technical Product Management

    1 month ago

    New York, United States X4 Technology Full time

    Role: VP of Technical Product ManagementIndustry: Payments TechnologyLocation: New York (Hybrid)Salary: $200k+ (depending on experience)A cutting-edge payments and loyalty platform that is revolutionizing the way independent restaurants connect with their guests are seeking a VP of Technical Product Management. You will lead their product vision and drive...

  • VP of Operations

    3 weeks ago

    New York, New York, United States Raycon, Inc. Full time

    Job Title: VP of OperationsRaycon, Inc. is seeking an experienced VP of Operations to lead the development of a world-class operations infrastructure to support our rapid growth. The ideal candidate will have a proven track record of scaling a fast-paced e-commerce company and possess expertise in operational excellence, process optimization, analytics, and...

  • VP of Technical Product Management Lead

    3 weeks ago

    New York, New York, United States X4 Technology Full time

    Job Title: VP of Technical Product ManagementAt X4 Technology, we are seeking a highly skilled and experienced VP of Technical Product Management to lead our product vision and drive the development of innovative solutions that enhance guest engagement and restaurant success.The successful candidate will have a deep understanding of technical product...

  • VP of Operations

    3 days ago

    New York, New York, United States Raycon, Inc. Full time

    Job Title: VP of OperationsRaycon, Inc. is seeking an experienced VP of Operations to lead the development of a world-class operations infrastructure to support our rapid growth. The ideal candidate will have a strong background in operational excellence, process optimization, and analytics, with experience scaling a fast-paced e-commerce company.Key...

  • PET Supplier Quality Manager-CMC

    4 days ago

    New Bedford, Massachusetts, United States Lantheus Full time

    Lantheus is a leading company in the field of medical imaging, with a strong presence in Bedford, Massachusetts, Canada, and Sweden.We are seeking a highly skilled Quality Assurance Manager to support our Chemistry, Manufacturing & Controls (CMC) aspects for the PET Supplier Quality Team.The ideal candidate will have experience in CMC authoring and will...

  • PET Supplier Quality Manager-CMC

    2 weeks ago

    New Bedford, Massachusetts, United States Lantheus Full time

    Lantheus is a leading company in the field of medical imaging, with a strong presence in Bedford, Massachusetts, and offices in Canada and Sweden. We are committed to pioneering innovative diagnostics, targeted therapeutics, and artificial intelligence solutions that empower clinicians to find, fight, and follow disease. Our purpose and values guide our...

  • PET Quality Manager

    3 weeks ago

    New Bedford, Massachusetts, United States Lantheus Full time

    About the RoleLantheus is a leading company in the medical imaging industry, with a strong presence in Bedford, Massachusetts, Canada, and Sweden. We are seeking a highly skilled Quality Manager to join our PET Supplier Quality Team.Key ResponsibilitiesAuthor and review CMC sections of regulatory filings for radiopharmaceuticals.Collaborate with technical...

  • PET Supplier Quality Manager-CMC

    4 weeks ago

    New Bedford, Massachusetts, United States Lantheus Full time

    About the RoleLantheus is a leading company in the field of medical imaging, and we are seeking a highly skilled Quality Manager to join our team. As a Quality Manager, you will be responsible for ensuring the quality of our PET suppliers and ensuring compliance with regulatory requirements.Key ResponsibilitiesAuthor and review CMC sections of regulatory...

  • Associate Director of Technical Operations

    2 weeks ago

    New York, New York, United States Axsome Therapeutics, Inc. Full time

    About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and delivering innovative therapies for the management of central nervous system (CNS) disorders. Our team is a dynamic group of professionals committed to addressing unmet needs for patients with CNS disorders. Our company is based in New York...

  • Associate Director of Technical Operations

    1 month ago

    New York, New York, United States Axsome Therapeutics, Inc. Full time

    About Axsome Therapeutics, Inc.Axsome Therapeutics, Inc. is a biopharmaceutical company dedicated to developing and delivering innovative therapies for the management of central nervous system (CNS) disorders. Our team is a dynamic group of professionals committed to addressing unmet needs for patients with CNS disorders. We are based in New York City.About...

  • VP, Quality Operations Manager

    4 weeks ago

    New York, New York, United States Kira Learning Full time

    Job Title: VP, Quality OperationsKira Learning is a leading provider of AI-powered learning solutions, and we're seeking a highly skilled VP, Quality Operations to join our team.As a key member of our leadership team, you will be responsible for driving quality and operational excellence across our organization. Your expertise will help us ensure that our...

  • VP, Operations

    1 month ago

    New York, New York, United States Kira Learning Full time

    About Kira LearningKira Learning is a pioneering education technology company that is revolutionizing the way computer science and artificial intelligence are taught and learned. Our mission is to empower teachers and prepare students for a world where technology and science play a pivotal role in everyone's lives.About this RoleWe are seeking a highly...

  • VP, Quality Operations Manager

    4 weeks ago

    New York, New York, United States Kira Learning Full time

    Job Title: VP, Quality OperationsKira Learning is a leading provider of AI-powered learning solutions, and we're seeking a highly skilled VP, Quality Operations to join our team.As a key member of our leadership team, you will be responsible for driving quality and operational excellence across our organization. This includes building and managing financial...

  • VP of Enterprise Integration

    2 weeks ago

    New York, New York, United States Apple & Associates Full time

    Job Title: VP of Enterprise IntegrationWe are seeking a highly experienced VP of Enterprise Integration to lead our team in crafting, integrating, and overseeing technology solutions within client environments across diverse travel sectors.About the Role:The Vice President of Business Integration will be responsible for leading a team focused on delivering...

  • Associate Director, Global Regulatory Sciences-CMC

    5 months ago

    New Brunswick, United States Bristol Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...