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Associate Director, Drug Product

April 28, 2026

<meta><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">About the role</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;">The Associate Director, Drug Product will serve as a technical and operational leader responsible for late-stage development, manufacturing, and commercialization activities for small molecule and/or viral drug products. Through operational oversight, technical mentorship, and cross-functional collaboration, the Associate Director will ensure drug product development and manufacturing deliverables across clinical and commercial programs is robust, compliant, and aligned with overall program objectives. The ideal candidate brings extensive hands-on experience in drug product process development and manufacturing, strong partnership experience with contract development and manufacturing organizations (CDMOs), proven ability to lead, develop, and mentor high-performing teams, and demonstrated success authoring drug product modules for BLAs and global marketing applications. Experience with viral formulations, in-use compatibility studies, and ex-US regulatory pathways is strongly preferred.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="color:rgb(0,0,0);background-color:rgb(255,255,255);font-size:15pt;white-space:pre-wrap;"> </strong></b><b><strong style="font-size:15pt;white-space:pre-wrap;">Location: </strong></b><span style="white-space:pre-wrap;">Remote</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Essential Functions</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Drug Product Development & Manufacturing </span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide technical and operational leadership across all aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide technical guidance on post-approval changes and lifecycle management strategies. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently.</span></li></ul></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Qualifications</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrated success authoring drug product BLA sections and supporting regulatory interactions. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Direct experience working with CDMOs and leading external manufacturing operations.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Proven people leader who develops talent and empowers teams. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrates strong cross‑functional leadership with the ability to navigate ambiguity and drive results in complex, fast‑paced environments.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Excellent written and verbal communication skill</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><u><i><b><strong style="text-decoration:underline;font-style:italic;white-space:pre-wrap;">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.</strong></b></i></u></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Total Rewards</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HIGHLY COMPETITIVE SALARIES </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE/MERIT REVIEWS</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE BONUSES</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">EQUITY</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">SPECIAL RECOGNITION</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Well-Being Benefits</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">FULLY REMOTE WORK ENVIRONMENT</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HOLIDAYS –In 2026 we will observe 14 holidays</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="white-space:pre-wrap;">CG Oncology is an Equal Opportunity Employer</strong></b><span style="white-space:pre-wrap;">:</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p>