Senior Scientist, Material Science and Technology

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The MSAT Senior Scientist is executing activities supporting the late-stage development and BLA readiness activities for our lead program, crestostimogene grenadenorepvec through our CDMOs. They will collaborate on the CMC development plan to monitor the course to BLA and commercialization of cretostimogene. They will be responsible to obtain and aggregate information upstream and downstream, monitor performance against KPIs and apprise Technical Operations/CMC leadership of progress and risks through regular communications and periodic reviews throughout development and in support of filings and approvals. The MSAT Senior Scientist reports to the Senior Director of MSAT within Technical Operations

Location: Remote

Essential Functions

• Technical Expertise:
• • Provide technical support for bioprocess development, including cell culture, virus production, purification, and formulation.
  • Review executed cGMP documents, extract data from provided documentation to allow data trending
  • Oversee process activities during cGMP manufacturing at CDMO
  • Strong technical writing abilities to support report writing and generation of regulatory filing
• Collaboration and Communication:
• • Collaborate with CDMOs on activities related to cGMP manufacturing, process development and optimization, troubleshooting and process scale-up
  • Work with process development, manufacturing, quality assurance, and regulatory teams to ensure seamless process transfer and integration.
  • Prepare and present technical reports, summaries, and presentations to internal and external stakeholders.
• Regulatory Compliance:
• • Ensure processes comply with regulatory requirements, including Good Manufacturing Practices (GMP).
  • Support documentation for regulatory submissions and audits.
• Innovation and Continuous Improvement:
• • Stay current with industry trends and technological advancements to drive innovation in process development.
  • Review and prepare implementation plans for continuous improvement initiatives to enhance process efficiency, yield, and product quality.
• Project Management:
• • Assists in developing timelines and allocation of resources in support of the Project Management group
  • Coordinate with project teams to ensure project milestones are met.
• Reporting and Accountability:
• • Report progress, challenges, and key performance indicators to the Senior Director of MSAT.
  • Ensure alignment of process development activities with broader technical operations and company goals.

Qualifications

• Master in Biochemistry, Biotechnology, Chemical Engineering, or a related field, or a BSc degree with extensive relevant experience.
• Minimum of 5 years of experience in bioprocess development, preferably in the Gene Therapy industry.
• Hands-on experience with cell culture, virus production, chromatography, and other bioprocessing techniques.
• Expertise in viral vector production or