Director of Viral Vector Process Development

3 days ago

Rapid City, South Dakota, United States GenScriptProBio Full time
{"Job Title": "Director of Viral Vector Process Development", "Job Description": "About GenScript

GenScript Biotech Corporation is a global biotechnology group with a presence across North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, the company has established itself as a leading player in the industry.

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.

The company is committed to making humans and nature healthier through biotechnology.

About ProBio

ProBio provides end-to-end CDMO services 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 development.

The company's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

ProBio has supported several mRNA vaccine global enterprises to obtain clinical approvals.

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 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:

The Director will build and lead a high-performing global team focused on viral vector process development.

The team will be responsible for developing and optimizing viral vector manufacturing processes, ensuring compliance with regulatory standards, and collaborating with other departments to meet corporate objectives.

Requirements:
  1. B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science field.
  2. Extensive industrial experience in viral vector process development and clinical manufacturing within the biopharmaceutical industry.
  3. In-depth knowledge of Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies.
  4. Proven leadership experience with a track record of successfully leading global teams.
  5. Strong understanding of cGMP regulations and compliance in a manufacturing environment.
  6. Excellent written and verbal communication skills, with the ability to effectively communicate complex technical concepts to diverse audiences.
"}

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