About the Role
Biogen is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for the development of small molecule oral drug products. This role leads formulation and process development across clinical programs, with a focus on enabling technologies for challenging compounds, clinical manufacturing readiness, and technology transfer. The role requires the ability to manage multiple interfaces with manufacturing, quality, regulatory CMC, other technical functions. 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.
Serve as the 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.
Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.
Oversee completion of drug product sections for regulatory submissions and related technical documentation.
Required Skills
PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline with a minimum of 10 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.
Strong understanding and hands on experience with oral solid dose manufacturing unit operations and manufacturability considerations.
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.
Preferred Skills
Deep expertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.
Experience implementing new technologies, digital tools, knowledge platforms, or best practices across multiple programs.
Demonstrated success managing external CDMO/CMO relationships and technology transfer activities.
Experience with late-stage development, commercial readiness, process characterization, and process validation.
Job Level: Management
Additional Information
The base compensation range for this role is: $159,000.00-$219,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a…