United States onlyAbout 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 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
Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.
Total Rewards
CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.
- HIGHLY COMPETITIVE SALARIES
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
Well-Being Benefits
In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.
Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2025 we will observe 14 holidays
- RETIREMENT – 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
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
CG Oncology is an Equal Opportunity Employer:
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.
