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Associate Director, Drug Product

CG Oncology, Inc. · Remote (United States), United States · Remote · Active · $166,000–$195,000 / year · Rippling ATS

Job facts

FieldValue
CompanyCG Oncology, Inc.
TitleAssociate Director, Drug Product
Normalized title-
Department / teamTechnical Operations
LocationUnited States
Work modelRemote / Remote
Employment typeFull Time
Salary$166,000–$195,000 / year
Statusactive
ATS providerRippling ATS
Posted / first seen2026-04-14 / 2026-05-29
Changed / last seen2026-06-06 / 2026-06-06

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Company jobsActive postings from CG Oncology, Inc..Open
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ATS provider jobsActive postings observed through Rippling ATS.Open
Provider filtered searchThe same provider as a filtered job collection.Open
Department jobsActive postings in Technical Operations.Open
Work model jobsActive Remote postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyCG Oncology, Inc.
Source450a8a94-2c0b-486c-85ea-0b4fe13e58d3
ATS providerRippling ATS

Description

company About CG Oncology, Inc. A re 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. role About the role 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. Location: Remote Essential Functions Drug Product Development & Manufacturing 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. Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations. Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests. Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities. Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution. Provide technical guidance on post-approval changes and lifecycle management strategies. Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently. Qualifications Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline. 8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies. Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations. Demonstrated success authoring drug product BLA sections and supporting regulatory interactions. Direct experience working with CDMOs and leading external manufacturing operations. Proven people leader who develops talent and empowers teams. Demonstrates strong cross‑functional leadership with the ability to navigate ambiguity and drive results in complex, fast‑paced environments. Excellent written and verbal communication skill 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 2026 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.

Full job record

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Org ID6a707b83-74d8-49ac-a126-cdb325d5a4c2
Source ID450a8a94-2c0b-486c-85ea-0b4fe13e58d3
Board ID450a8a94-2c0b-486c-85ea-0b4fe13e58d3
Providerrippling
Provider Job Key088faed5-7b8f-406c-a755-ddb809a01b18
TitleAssociate Director, Drug Product
Normalized Title
Statusactive
Activeyes
Location TextRemote (United States), United States
DepartmentTechnical Operations
Team
Employment Typefull_time
Workplace Typeremote
Remote Policyremote
CountryUnited States
Region
City
Salary RawUSD 166000-195000 YEAR
Salary Min166,000
Salary Max195,000
Salary CurrencyUSD
Salary Periodyear
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Apply URLhttps://ats.rippling.com/cgoncologycareers/jobs/088faed5-7b8f-406c-a755-ddb809a01b18
First Seen At2026-05-29 07:15:00Z
Last Seen At2026-06-06 20:03:50Z
Last Checked At2026-06-06 20:03:50Z
Last Changed At2026-06-06 20:03:50Z
Inactive At
Source Posted At2026-04-14 21:56:30Z
Source Updated At
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      "role": "<meta><p style=\"font-family:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 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 &amp; 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:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px 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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 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&nbsp;&nbsp;&nbsp;</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:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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.&nbsp; 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:&quot;Basel Grotesk&quot;,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.&nbsp; 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:&quot;Basel Grotesk&quot;,Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 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 &amp; 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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:&quot;Basel Grotesk&quot;,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;\">&nbsp;</span></p><p style=\"font-family:&quot;Basel Grotesk&quot;,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:&quot;Basel Grotesk&quot;,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>",
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