Director, Drug Product

Role: Director of Drug Product

leading formulation and process development for small-molecule and biologic therapeutics in oncology.

Objectives: oversee portfolio programs from candidate assessment through commercialization, ensuring scalable, high-quality drug products meeting regulatory standards.

Responsibilities

• define phase-appropriate drug product strategies;
• lead formulation, process development, scale-up, and technology transfer;
• manage clinical supply manufacturing and external partners;
• develop control strategies and support regulatory submissions;
• provide technical guidance and manage cross-functional collaborations.

Requirements

• BS/MS/PhD in Pharmaceutical Sciences, Chemical/Biochemical Engineering, or related field;
• 8+ years in drug product development/manufacturing for small molecules and biologics;
• extensive experience in early and late-stage development, including IND-enabling work, process validation, and commercial readiness.

High-Value Expertise

• expertise in dosage form development, biologic formulation, aseptic fill-finish, cGMP, QbD, FDA/EMA/ICH compliance, and management of CROs/CDMOs.

Work Setup

based in Redwood City, CA; salary range $211K-$264K, with full benefits and equity, reporting to senior leadership, potentially managing a team.