Director, Formulation and Drug Product Development

Position Overview
Director, Formulation and Drug Product Development to lead formulation and process development for complex biologics (emphasis on bispecifics and fusion proteins), progressing into pivotal studies and commercial readiness. Oversees drug product control strategy, process validation, and BLA/MMA submissions.

Responsibilities
- Develop drug product development strategies through internal/external partnerships and integration into drug/device combination products.
- Oversee, scale-up, and characterize manufacturing processes, including sterile filtration, filling/finish, and lyophilization.
- Oversee drug product development activities to ensure successful tech transfer, characterization, and process validation.
- Serve as subject matter expert in high-concentration formulation development (aggregation, viscosity, sub-visible particles).
- Provide technical guidance at CMOs/CROs and review technical development documents.
- Develop regulatory strategies and draft submissions including INDs, IMPDs, BLAs, and MAAs.
- 20–25% travel in support of manufacturing and development at CDMOs.
- Collaborate cross-functionally (analytical development, quality assurance, regulatory affairs, manufacturing).

Qualifications
- M.S. with 12+ years or Ph.D. in biochemical engineering, chemical engineering, biochemistry, or pharmaceutical sciences with 8+ years industrial experience.
- Formulation/drug product process development for complex biologics (bispecifics, fusion proteins).
- Experience developing/characterizing lyophilized drug product processes.
- High-concentration formulation development experience (preferred).
- Regulatory filing authorship (IND/IMPD/BLA/MAA).
- Manage cross-functional teams.
- Knowledge of QbD, cGMP, and CMC requirements (US/Europe).
- Strong written/verbal communication with interdisciplinary teams.
- Understanding of FDA/EMA/ICH guidelines.
- Experience defining late-stage biologics drug development strategy.