Principal Scientist, Oral Formulation Development
About The Position
Biogen is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for the development of small molecule oral drug products. The role leads formulation and process development across clinical programs, focusing on enabling technologies for challenging compounds, clinical manufacturing readiness, and technology transfer. It involves managing interfaces with manufacturing, quality, regulatory CMC, and other technical functions, managing external partnerships, and advancing technologies and workflows that strengthen oral drug product development capabilities. The Principal Scientist leads formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage forms across development stages. The role represents drug product on cross-functional CMC and asset teams, influences portfolio decisions through technical and development assessments, and oversees drug product sections for regulatory submissions and related technical documentation.
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.
Nice To Haves
- 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.
Responsibilities
- 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.
- Manage external partnerships and advance new technologies and workflows that strengthen oral drug product development capabilities.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness and wellness programs, including fitness reimbursement
- Short- and long-term disability insurance
- At least 15 days of paid vacation and year-end shutdown time off (December 26–31)
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid maternity and parental leave
- 401(k) program with company-matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term cash bonus and long-term equity incentive opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
