Senior Scientist, Material Science and Technology

CG Oncology

122d

About The Position

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.

Requirements

• 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 general complex biotechnology processes.
• In-depth understanding of bioprocessing principles and practices.
• Familiarity with regulatory requirements and quality standards for biopharmaceutical manufacturing.
• Strong technical writing skills.

Responsibilities

• 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.
• 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.
• Ensure processes comply with regulatory requirements, including Good Manufacturing Practices (GMP).
• Support documentation for regulatory submissions and audits.
• 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.
• Assist in developing timelines and allocation of resources in support of the Project Management group.
• Coordinate with project teams to ensure project milestones are met.
• 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.

Benefits

• Highly competitive salaries.
• Annual performance/merit reviews.
• Annual performance bonuses.
• Equity.
• Special recognition.
• Fully remote work environment.
• Unlimited flexible time off.
• 14 holidays in 2025.
• 401K with 100% company Safe Harbor match up to 4% of base salary.
• Health (medical, dental, vision) – PPO & HDHP – Cigna/Principal.
• Health spending accounts - HSA (with annual company contribution), FSA, FSA-DC.
• Company paid LTD coverage + voluntary plans for illness & disability protection.
• Company paid life insurance 1 x base salary + voluntary plans.
• Additional exclusive benefits – voluntary legal, pet, plus more.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Master's degree
• Number of Employees: 101-250 employees