Viral Vector Process Development Director

2 weeks ago


Princeton, New Jersey, United States Life Science People Full time
Job Title: Director of Viral Vector Process Development

Life Science People is seeking a highly experienced and skilled Director of Viral Vector Process Development to lead our process development, optimization, and scale-up of viral vector manufacturing within the organization.

Key Responsibilities:
  • Strategic Planning: Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.
  • Process Development: Lead and drive the development of viral vector-based manufacturing processes to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.
  • Experimentation and Design: Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.
  • Process Transfer: Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
  • Regulatory Compliance: Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).
  • Quality Control: Maintain rigorous quality control standards throughout the process development lifecycle.
  • Documentation and Audits: Prepare and review documentation for regulatory submissions and audits.
  • Collaboration and Communication: Collaborate with manufacturing teams to troubleshoot and resolve production issues, and communicate project progress, challenges, and strategic plans to senior management and stakeholders.
Team Leadership:
  • Team Building: Build and lead a high-performing global team focused on viral vector process development.
  • Supervision and Mentorship: Supervise a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and fostering a collaborative work environment.
  • Problem-Solving and Adaptability: Demonstrate strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving technical challenges, and thrive in a fast-paced, dynamic environment.
Requirements:
  • Education: B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science field.
  • Experience: Extensive industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical industry.
  • Knowledge and Skills: In-depth knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies, as well as strong leadership experience with a track record of successfully leading global teams.
  • Regulatory Knowledge: Strong understanding of cGMP regulations and compliance in a manufacturing environment.
  • Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex technical concepts to diverse audiences.


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