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.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.