Head of Viral Vector Process Engineering
2 weeks ago
The Director of Process Development will spearhead the advancement, refinement, and scaling of viral vector production within the organization. This position entails overseeing a team of process development professionals, ensuring the establishment of robust and scalable manufacturing protocols, 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 analysis and experimental design techniques.
- Oversee the transition of plasmid and viral vector processes from research and development to production, ensuring smooth integration and compliance with regulatory requirements.
- Guarantee that all process development undertakings adhere to pertinent regulatory guidelines (FDA, EMA, etc.).
- Uphold stringent quality control measures throughout the process development lifecycle.
- Prepare and evaluate documentation for regulatory submissions and inspections.
- Collaborate with manufacturing teams to identify and resolve production challenges.
- Engage with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to synchronize process development initiatives.
- Communicate project advancements, obstacles, and strategic plans to senior leadership and stakeholders.
- Represent the organization at scientific conferences, industry gatherings, and in scholarly publications.
- Stay informed about industry trends and innovations to enhance the organization's capabilities in viral vector technology.
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, providing mentorship and fostering a collaborative environment.
- Exhibit strong analytical and problem-solving skills, proactively addressing and resolving technical challenges.
- Collaborate effectively with cross-functional teams and external partners to achieve shared objectives.
- Adapt to a fast-paced, dynamic environment while managing shifting priorities and requirements.
- Offer mentorship and support to team members to promote professional development.
Qualifications:
- B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a related biological science discipline.
- Extensive 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 successful track record of 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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Princeton, New Jersey, United States Life Science People Full timeThe 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...
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Princeton, New Jersey, United States Life Science People Full timeThe 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...
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