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Director, Oral Drug Product Development

Biogen

Cambridge, MAStaffH-1B sponsor company
Sign in to applyVerified 2h ago
Location
Cambridge, MA
Work model
On-Site
Level
Staff
H-1B history
30 approvals (FY2023)
Posted
Aug 14, 2026

About this role

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   s cie nt ifi c   and   en gin eering e ff orts   supp orting   formulation and process development across early- and late-stage programs .   This t e chnical   lead   wil l d rive   enabling technologies for   typ ically   low   so lubil ity   and   lo w perm eabil ity   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.   What   You’ll   Do 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   su ch as   orally   delivered   pe pti des .   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 developability, 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.

Who You Are

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.

Required Skills

PhD in   Pharmaceutical Sciences,   Chemical Engineering, Chemistry ,   or a related scientific discipline   with a minimum of 1 2   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

Listing verified 2h ago. Applications go through the company's official careers site.

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Director, Oral Drug Product Development at Biogen, Cambridge, MA | Yoinka