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 Senior Director CMC Process Development & MSAT is responsible for the Technology Transfer, process development and scale up of Cretostimogene (AV) drug substance process. In this technical and strategic leadership role, the individual will lead drug substance activities at contract development and manufacturing organizations (CDMOs) with the goal of delivering clinical and commercial drug product batches meeting the company’s current and future needs.

Location: Remote

Essential Functions

• Lead technology transfer team(s) responsible for end-to-end transfer of knowledge, process and technology developed by the CGO technical teams for vector product manufacturing to CGO chosen manufacturing sites.
• Troubleshoot manufacturing issues at contract & strategic partners. In collaboration with Technical Operations partners (manufacturing, quality, supply, project management, etc.), ensure timely support for tech transfer, product/process investigations, training, and improvement projects.
• Support Tech Ops team in Developing 2nd generation drug substance processes targeting reduced COGs and improved manufacturability , timelines, and development plans in collaboration with broader global team including project management, MS&T, QC, QA, and regulatory members.
• Acts as a Subject Matter Expert for the implementation of phase appropriate process development and optimization, manufacturing, and validation activities at external CDMOs by following the FDA guidance and QbD principles in accordance with documented work plans and cGMP requirements to ensure on time delivery of clinical trial materials (CTM).
• Reviews Draft, Master, and Executed Batch Records, protocols and reports related to all GMP operations related to the finished product.
• Provides technical leadership and communicates clearly and concisely across multiple business functions, building effective relations with internal and external partners.
• Participates in GMP investigations; develops corrective action plans and implements such plans to resolve process and product issues.
• Work collaboratively with Quality Assurance and Regulatory Affairs to ensure a high level of cGMP compliance.
• Assist in the technical aspects of the company’s regulatory filings, including process validation for the upcoming BLA filing.

Qualifications

• Bachelor’s Degree in relevant/scientific field, or extensive relevant experience in lieu of degree. Advance degree is preferred.
• Minimum of fifteen (15) years of experience in the biopharmaceutical industry.
• Work experience with both upstream and downstream aspects of drug substance development and production.
• Experience working with or in a contract manufacturing environment with an in-depth knowledge of unit operations for clinical/commercial drug substance and drug products.
• Knowledge of drug substance and drug product process development.
• Ability to effectively work with external CDMOs to meet the timelines while staying within approved budgets – in a remote or on location capacity.
• Ability to effectively work independently in a team environment with the internal department including, but not limited to, the MS&T, Analytical, Regulatory, Clinical Supplies, and Quality Assurance Department in a fast-paced collaborative environment.
• Ability to travel up to 25% of the time.

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.