Associate Director, Drug Product

CG Oncology

Associate Director leading drug product development and manufacturing at CG Oncology. Ensuring robust and compliant deliverables for clinical and commercial programs.

Posted 4/16/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $166,000 - $195,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

HIGHLY COMPETITIVE SALARIES
ANNUAL PERFORMANCE/MERIT REVIEWS
ANNUAL PERFORMANCE BONUSES
EQUITY
SPECIAL RECOGNITION
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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug product developmentmanufacturingformulationaseptic processingclinical in-use studiesregulatory filingsBLA authoringlifecycle managementcGMPICH guidelines

Soft Skills

technical leadershipcross-functional leadershippeople developmentempowermentcommunicationdecision-makingnavigating ambiguitydriving resultsteam alignmenttalent development

Certifications

PhDMSBS