Director, Oral Drug Product Development

About the Role

Biogen is seeking a Director, Oral Drug Product Development to provide scientific and strategic leadership for the development of small molecule oral drug products. This role leads scientific and engineering efforts supporting formulation and process development across early- and late-stage programs. This technical lead will drive enabling technologies for typically low solubility and low permeability compounds, clinical manufacturing readiness, technology transfer, and commercialization.

The Director serves as a senior drug product leader and mentor on cross-functional CMC and asset teams, influencing development strategy, manufacturing readiness, and regulatory submissions. This role will also be responsible for managing external partnerships and advancing new technologies and workflows that strengthen Biogen’s oral drug product development capabilities.

• Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage forms across all stages of development.
• Develop enabling formulation approaches for challenging compounds, including poorly soluble, poorly permeable, unstable, or complex molecules such as orally delivered peptides.
• Serve as the senior drug product representative on cross-functional CMC and asset teams, driving alignment across regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
• Influence portfolio decisions through assessment of develop ability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
• Champion technology transfer, clinical manufacturing readiness, and scale-up activities at internal and external manufacturing sites.
• Provide strategic oversight and establish manufacturing strategies.
• Mentor and develop scientists and engineers supporting oral drug product development.
• Oversee completion of drug product sections for regulatory submissions and related technical documentation.
• Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.

You are an innovative scientific leader with a passion for advancing drug development processes through rigorous science and data-driven decision-making. You excel at transforming experimental findings into development strategies, using deep technical expertise and sound scientific judgment to solve complex drug product challenges. Your expertise drives you to develop cutting-edge solutions ensuring manufacturability, scalability, and readiness for commercialization. You thrive in collaborative environments, influencing strategic decisions, and fostering alignment across diverse functions.

Your mentoring skills inspire teams to achieve excellence, while your forward-thinking approach maximizes Biogen's capabilities in oral drug product development.

• PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline with a minimum of 12 years’ experience in oral drug product development.
• Demonstrated track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing and/or late-stage development.
• Experience with scale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.
• Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies.
• Proven ability to lead across functions, influence program strategy, manage technical risk, and communicate effectively with diverse stakeholders.
• Experience mentoring, developing, or leading scientists and engineers.

• Deep expertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.
• Experience with late-stage development, commercial readiness, process characterization, or process validation.
• Experience supporting at least one NDA/MAA…