Director, Formulation and Drug Product Development

Position Overview

Bicara Therapeutics is seeking a Director, Formulation and Drug Product Development who will lead the formulation and process development for complex biologics, with a strong emphasis on bispecifics, and fusion proteins, progressing into pivotal studies and commercial readiness. This role oversees drug product control strategy, process validation, and BLA/MMA submissions.

The ideal candidate will bring expertise in late-stage development and establishment of drug product control strategies for bispecifics and fusion proteins including experience with Liguid/Lyo process development strategies, and high concentration formulation development.

Responsibilities

• Develop drug product development strategies through internal/external partnerships and product integration into drug/device combination products.
• Oversee, scale-up, and characterize drug product manufacturing processes, including sterile filtration, filling/f...