Head of Viral Vector Process Engineering

2 weeks 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 process development scientists and engineers, ensuring the establishment of robust and scalable production methodologies, and collaborating closely with various departments to fulfill organizational goals and adhere to regulatory standards.

Key Responsibilities:

  • Formulate strategic initiatives for vector process development that align with the organization’s objectives and regulatory frameworks.
  • Lead the innovation and enhancement of viral vector-based manufacturing processes (e.g., AAV, lentivirus, retrovirus) to boost efficiency, scalability, and product integrity.
  • Design and supervise experiments aimed at assessing and refining viral vector production methodologies, employing statistical techniques 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 conform to 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 with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to synchronize process development efforts.
  • Communicate project advancements, 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 innovations to enhance the organization’s capabilities in viral vector technologies.

Team Leadership:

  • Build and lead a high-performing global team dedicated to 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.
  • Thrive in a fast-paced, dynamic environment, adapting to evolving 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.
  • 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, capable of conveying complex technical concepts to diverse audiences.

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