Director of Viral Vector Process Development

Job Description:

The Director of Viral Vector Process Development will lead the process development, optimization, and scale-up of viral vector manufacturing within the organization. The Director will manage a team of process development scientists and engineers, ensure robust and scalable production processes, and work closely with other departments to meet corporate objectives and regulatory standards

Responsibilities:

1. Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.
2. Lead and drive the development of viral vector-based (e.g., AAV, lentivirus, retrovirus) manufacturing processes to improve efficiency, scalability, and product quality, with a focus on innovation and optimization.
3. Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.
4. Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
5. Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).
6. Maintain rigorous quality control standards throughout the process development lifecycle.
7. Prepare and review documentation for regulatory submissions and audits.
8. Collaborate with manufacturing teams to troubleshoot and resolve production issues.
9. Work closely with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to align process development
10. Communicate project progress, challenges, and strategic plans to senior management and stakeholders.
11. Represent the company at scientific conferences, industry meetings, and in publications.
12. Stay abreast of industry trends and advancements to enhance ProBio's virus-related capabilities.

• Team Leadership:

1. Build and lead a high-performing global team focused on viral vector process development.
2. Supervise a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and fostering a collaborative work environment.
3. Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving technical challenges.
4. Proven ability to collaborate effectively with cross-functional teams and external partners to achieve common objectives.
5. Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and requirements.
6. Provide mentorship, guidance, and support to team members to foster professional growth.

Requirements:

• B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology and a relevant biological science field.
• Extensive industrial experience (Job level depends on experience) in viral vector process development and clinical manufacturing within the biopharmaceutical industry.
• 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 communicate complex technical concepts to diverse audiences.