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Director of Viral Vector Process Development

2 months ago

Rapid City, South Dakota, United States GenScriptProBio Full time
About GenScript/ProBio

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group with a presence across North America, Europe, the Greater China, and Asia Pacific. Founded in 2002, GenScript has established itself as a leading player in the biotech industry.

About ProBio

ProBio is a division of GenScript that provides end-to-end CDMO services from drug discovery to commercialization. Our team of experts is dedicated to accelerating drug development for our customers.

Job Description

We are 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. The successful candidate will manage a team of process development scientists and engineers, ensuring robust and scalable production processes that meet corporate objectives and regulatory standards.

Key Responsibilities
  • Develop strategic plans for vector process development in alignment with organizational goals and regulatory requirements.
  • Lead and drive the development of viral vector-based manufacturing processes to improve efficiency, scalability, and product quality.
  • Design and oversee experiments to evaluate and improve viral vector production processes, utilizing statistical methods and experimental design principles.
  • Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards.
  • Ensure all process development activities comply with relevant regulatory guidelines (FDA, EMA, etc.).
  • Maintain rigorous quality control standards throughout the process development lifecycle.
  • Prepare and review documentation for regulatory submissions and audits.
  • Collaborate with manufacturing teams to troubleshoot and resolve production issues.
  • Work closely with internal departments (e.g., Quality Assurance, Quality Control, Manufacturing) to align process development activities.
  • Communicate project progress, challenges, and strategic plans to senior management and stakeholders.
  • Represent the company at scientific conferences, industry meetings, and in publications.
  • Stay abreast of industry trends and advancements to enhance ProBio's virus-related capabilities.
Requirements
  • B.S. and/or advanced degree in Chemical Engineering, Biochemistry, Virology, or a relevant biological science field.
  • Extensive industrial 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.