Scientist, Drug Product

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 Drug Product Scientist at CG Oncology will be responsible for leading formulation development/characterization, clinical in-use studies, and other drug product activities as part of the Technical Operations - CMC team. This position will play a critical role in identifying stable formulations, tech transfer into manufacturing and supporting regulatory submissions for our novel bladder cancer therapies. The Scientist will collaborate closely with internal stakeholders and Contract Research Organizations (CRO) to design studies, analyze data, and ensure consistent product quality and stability for clinical and commercial products.

Location: Remote

Essential Functions

• Oversee formulation development and characterization studies to identify stable and robust formulations for novel bladder cancer therapies.
• Understand analytical assays, critical quality attributes, and critically assess analytical and stability data to make decisions and design subsequent experiments for virus-based therapies.
• Design and execute clinical in-use studies to meet regulatory expectations and ensure consistent product quality through administration.
• Support sterile drug product process characterization, validation and manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs).
• Coordinate review of documentation to ensure on-time execution of development and manufacturing activities.
• Collaborate with cross-functional teams, including Process Development, Manufacturing, Analytical Development and Regulatory Affairs, to align development and manufacturing timelines and strategies to ensure alignment with overall project objectives.
• Analyze data from studies and generate comprehensive reports, summarizing key findings, conclusions and recommendations.
• Author sections of regulatory filings, review and author response to regulatory questions.
• Stay abreast of publications, industry best practices, regulatory guidelines, and emerging trends in formulation and drug product development through literature review, participation in scientific conferences, and collaboration with external experts.

Qualifications

• Bachelor’s degree in chemical engineering, Pharmaceutical Sciences, or related field.
• Three to five years of relevant experience in formulation development and characterization, clinical in-use, drug product manufacturing, or related areas within the pharmaceutical or biotechnology industry.
• Technical Proficiency: Proficiency in statistical analysis software (e.g., JMP, Minitab) and Microsoft Office suite.
• Strong understanding of product stability, formulation robustness and analytical assays for virus products
• Understanding of sterile drug product manufacturing processes
• Familiarity with FDA and ICH guidelines for pharmaceutical development
• Understanding of cGMP regulations
• Experience working with CROs and CDMOs

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.