Viral Vector Process Development Director
2 weeks ago
Life Science People is seeking a highly experienced and skilled Director of Viral Vector Process Development to lead our process development, optimization, and scale-up of viral vector manufacturing within the organization.
Key Responsibilities:- Strategic Planning: Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.
- Process Development: Lead and drive the development of viral vector-based manufacturing processes to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.
- Experimentation and Design: Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.
- Process Transfer: Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
- Regulatory Compliance: Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).
- Quality Control: Maintain rigorous quality control standards throughout the process development lifecycle.
- Documentation and Audits: Prepare and review documentation for regulatory submissions and audits.
- Collaboration and Communication: Collaborate with manufacturing teams to troubleshoot and resolve production issues, and communicate project progress, challenges, and strategic plans to senior management and stakeholders.
- Team Building: Build and lead a high-performing global team focused on viral vector process development.
- Supervision and Mentorship: Supervise a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and fostering a collaborative work environment.
- Problem-Solving and Adaptability: Demonstrate strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving technical challenges, and thrive in a fast-paced, dynamic environment.
- Education: B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science field.
- Experience: Extensive industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical industry.
- Knowledge and Skills: In-depth knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies, as well as strong leadership experience with a track record of successfully leading global teams.
- Regulatory Knowledge: Strong understanding of cGMP regulations and compliance in a manufacturing environment.
- Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex technical concepts to diverse audiences.
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Head of Viral Vector Process Engineering
2 months ago
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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Head of Viral Vector Process Engineering
2 months ago
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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