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/finish processes, and lyophilization.
• Oversee drug product development activities, ensuring successful tech transfer, characterization, and process validation.
• Provide technical guidance during investigations at CMOs/CROs and review technical development documents.
• Develop regulatory strategies and draft regulatory submissions including INDs, IMPDs, BLAs, and MAAs.
• 20-25% travel in support of manufacturing and development activities at CDMOs.
• Collaborate with cross-functional teams, including analytical development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and success.

Qualifications

• M.S. with 12+ years or a Ph.D. in biochemical engineering, chemical engineering, biochemistry, or pharmaceutical sciences, with at least 8+ years of experience in an industrial setting
• Formulation and drug product process development experience with complex biologics including bispecifics and fusion proteins
• Experience in development and characterizing lyophilized drug product processes
• Experience developing high concentration formulations preferred
• Experience in authoring regulatory filings (INDs, IMPDs, BLAs, MAAs)
• Experience in effectively managing cross functional teams
• Knowledge of Quality by Design principles, cGMP, and CMC requirements for regulatory filings globally, especially in the US and Europe
• Strong writing and verbal communication skills, and effectiveness in communicating with interdisciplinary and cross-functional teams
• Understanding of FDA, EMA, ICH guidelines associated with drug product development, characterization, and validation