Director of Viral Vector Process Development - GenScript

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, \ProBio has a stable and high-yield viral vector platform.

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.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.