Associate Director, Drug Product

CG Oncology

3d•Remote

About The Position

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

Requirements

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

Nice To Haves

Experience with viral formulations, in-use compatibility studies, and ex-US regulatory pathways is strongly preferred.

Responsibilities

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.