Director Process Development

2 months ago

Princeton, United States Life Science People Full time

The Director of Process Development will lead the process development, optimization, and scale-up of viral vector manufacturing within the organization. This role involves managing a team of process development scientists and engineers, ensuring robust and scalable production processes, and working closely with other departments to meet organizational objectives and regulatory standards.


Responsibilities:

  • Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.
  • Lead and drive the development of viral vector-based (e.g., AAV, lentivirus, retrovirus) manufacturing processes to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.
  • Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.
  • Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
  • Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).
  • Maintain rigorous quality control standards throughout the process development lifecycle.
  • Prepare and review documentation for regulatory submissions and audits.
  • Collaborate with manufacturing teams to troubleshoot and resolve production issues.
  • Work closely with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to align process development efforts.
  • Communicate project progress, challenges, and strategic plans to senior management and stakeholders.
  • Represent the organization at scientific conferences, industry meetings, and in publications.
  • Stay abreast of industry trends and advancements to enhance the organization's virus-related capabilities.


Team Leadership:

  • Build and lead a high-performing global team focused on viral vector process development.
  • Supervise a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and fostering a collaborative work environment.
  • Demonstrate strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving technical challenges.
  • Collaborate effectively with cross-functional teams and external partners to achieve common objectives.
  • Thrive in a fast-paced, dynamic environment and adapt to changing priorities and requirements.
  • Provide mentorship, guidance, and support to team members to foster professional growth.


Requirements:

  • B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science field.
  • Extensive industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical industry (job level depends on experience).
  • In-depth knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies.
  • Proven leadership experience with a track record of successfully leading global teams.
  • Strong understanding of cGMP regulations and compliance in a manufacturing environment.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex technical concepts to diverse audiences.

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