Head of Product Development and Manufacturing

4 weeks ago

Cambridge, United States Volnay Therapeutics Full time

Volnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell and gene therapy pipeline. You will play a pivotal role in developing state-of-art manufacturing processes and delivering well-characterized and commercially viable cell therapy products, with the ultimate goal of translating innovative science into real-world therapies for patients in need.


Responsibilities:

  • Manage and lead all external and internal aspects of process development, including upstream and downstream cell processing, viral vector production, and analytical development for Volnay’s cell therapy pipeline.
  • Build and lead a high-performing Product Development and Manufacturing team in defining and executing strategic plans for optimizing and scaling our cell and gene therapy manufacturing processes. Create and foster a collaborative and innovative work environment.
  • Collaborate closely with other internal and external teams and functions within the Volnay ecosystem ( e.g. Research & Development, Development Operations, Quality Assurance, and Regulatory Affairs) to ensure seamless development and regulatory compliance.
  • Lead and contribute to technology transfer activities, ensuring smooth transition from development to manufacturing. Manage technical and scientific collaborations with contract manufacturing organizations (CMOs) and technology vendors.
  • Drive continuous process and analytical improvement initiatives, with focus on product quality, process commercialization and reduction of COGS. Develop and implement novel process and analytical technologies and best practices to enhance process efficiency and product quality. Evaluate and develop novel platform technologies for cell therapy manufacturing through partnerships and co-development with technology companies.
  • Manage the Product Development and Manufacturing budget and resources effectively.
  • Represent Volnay at scientific conferences and industry events.


Qualifications:

  • Advanced degree (Ph.D. or M.s.) in Chemical Engineering, Biology, or a related field, with at least 10 years of experience in cell and gene therapy process development.
  • Proven track record of successfully developing and scaling-up cell and gene therapy manufacturing processes.
  • Extensive knowledge of current cell and gene therapy technologies, platforms, and regulatory requirements.
  • Strong leadership and team-building skills with the ability to motivate and mentor scientific teams.
  • Excellent communication and presentation skills, with the ability to effectively communicate complex technical concepts to diverse audiences.
  • Demonstrated ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment.
  • Strong analytical and problem-solving skills.


Total compensation and benefits are negotiable. To apply, please submit your resume and cover letter explaining why you are the ideal candidate for this position.


We look forward to hearing from you

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