Associate Director, Drug Product

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

The pay range for this role is: 166,000 - 195,000 USD per year (Remote) Apply tot his job Apply To this Job