Principal Scientist, Oral Formulation Development
Biogen
Summary
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.
Job description
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.
Requirements
- PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific discipline
- 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
Benefits
- Medical, Dental & Vision Insurance
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- Paid Vacation
- Paid Holidays
- Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.