Head of Viral Vector Process Engineering

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 that production methods are both robust and scalable, while 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.
  • Guide and enhance the development of viral vector-based manufacturing processes (e.g., AAV, lentivirus, retrovirus) aimed at boosting efficiency, scalability, and product excellence, with an emphasis on innovation and optimization.
  • Design and supervise experiments to assess and enhance viral vector production processes, employing statistical methodologies and principles of experimental design.
  • Oversee the transition of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and adherence to regulatory standards.
  • Guarantee that all process development activities comply 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, challenges, and strategic plans to senior management and stakeholders.
  • Represent the organization at scientific conferences, industry meetings, and in publications.
  • Stay informed about industry trends and advancements to enhance the organization's capabilities in viral vector technology.

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.
  • Exhibit strong analytical and problem-solving skills, with a proactive approach to 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 and adapt to evolving priorities and requirements.
  • Provide mentorship, guidance, and support to team members to promote professional growth.

Qualifications:

  • 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 sector (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 convey complex technical concepts to diverse audiences.


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