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Head of Viral Vector Process Development

2 months ago

Princeton, New Jersey, United States Life Science People Full time

The Director of Process Development will spearhead the advancement, refinement, and scaling of viral vector production within the organization. This pivotal role encompasses overseeing a team of scientists and engineers dedicated to process development, ensuring the establishment of robust and scalable production methodologies, and collaborating with various departments to fulfill organizational goals and adhere to regulatory standards.

Key Responsibilities:

  • Formulate strategic initiatives for vector process development that align with organizational objectives and regulatory frameworks.
  • Direct and enhance the development of viral vector-based manufacturing processes (e.g., AAV, lentivirus, retrovirus) to boost efficiency, scalability, and product excellence, emphasizing innovation and optimization.
  • Design and supervise experiments aimed at assessing and enhancing viral vector production processes, employing statistical methodologies and experimental design principles.
  • Oversee the transition of plasmid and viral vector processes from research and development to manufacturing, ensuring smooth integration and adherence to regulatory standards.
  • Guarantee that all process development activities are in compliance with pertinent regulatory guidelines (FDA, EMA, etc.).
  • Uphold stringent quality control standards throughout the process development lifecycle.
  • Prepare and evaluate documentation for regulatory submissions and audits.
  • Collaborate with manufacturing teams to troubleshoot and resolve production challenges.
  • Engage closely with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to synchronize process development efforts.
  • Communicate project progress, obstacles, and strategic plans to senior management and stakeholders.
  • Represent the organization at scientific conferences, industry gatherings, and in publications.
  • Stay informed about industry trends and advancements to enhance the organization's capabilities in viral technologies.

Team Leadership:

  • Build and guide a high-performing global team focused on viral vector process development.
  • Supervise a team of scientists and engineers involved in process development activities, providing mentorship and fostering a collaborative work environment.
  • Exhibit strong analytical and problem-solving skills, proactively identifying and addressing technical challenges.
  • Collaborate effectively with cross-functional teams and external partners to achieve shared objectives.
  • Excel in a fast-paced, dynamic environment, adapting to shifting priorities and requirements.
  • Provide mentorship, guidance, and support to team members to promote professional development.

Qualifications:

  • B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science discipline.
  • Extensive industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical sector (job level contingent on experience).
  • Comprehensive knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies.
  • Demonstrated leadership experience with a proven track record of successfully managing global teams.
  • Strong understanding of cGMP regulations and compliance in a manufacturing context.
  • Exceptional written and verbal communication skills, with the ability to convey complex technical concepts to diverse audiences.