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.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: Senior Scientist, Materials, Science & Technology (MSAT)

Location: Remote US-Based

Essential Functions:

Process Design and Optimization:

• Develop and optimize upstream and downstream processes for biopharmaceutical production.
• Design experiments, analyze data, and interpret results to improve process performance.
• Scale up processes from laboratory to pilot and production scale.

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

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:

• Masters 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.

The U.S. target annual salary range for this remote, full-time, position is currently set at $149,000 - $160,000. The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

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 the 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 - Unlimited Paid Time Off (PTO)
• HOLIDAYS – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• 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.

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.