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 - Serve as a subject matter expert on high concentration formulation development with experience in, control of aggregation, viscosity, and sub-visible particles - 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. - Experience in defining strategy for late-stage biologics drug development COMPANY OVERVIEW Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com http://www.bicara.com. Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We