Senior Scientist, Oral Formulation & Tech Transfer

Biogen, Inc.; Cambridge (MA); On-site; USD 159,000 - 219,000; Full time

Benefits offered by this job

Fitness reimbursement

Disability insurance

Paid vacation 15 days + shutdown time

Company holidays

Sick time

Parental Leave

401(k) with match

Employee stock purchase plan

Tuition reimbursement

Employee resource groups

Job summary

Biogen, Inc. is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for small molecule oral drug product development and technology transfer across clinical programs.

You will lead design, process development, and scale-up, driving manufacturability and regulatory readiness while partnering with manufacturing, quality, and external CDMOs to advance platforms and enable efficient portfolio execution.

Qualifications

• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related field with a minimum of 10 years’ experience in oral drug product development.
• Proven track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing.
• Strong understanding of oral solid dose manufacturing unit operations and manufacturability considerations.
• Experience with scale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.
• Deep knowledge of CMC development, regulatory expectations, and phase-appropriate development strategies.

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.

Skills

PhD in Chem Eng / Pharm Sci

Oral solid dosage development

Scale-up & technology transfer

CMC regulatory knowledge

Cross-functional leadership

Education

PhD in a relevant field

Tools

Regulatory documentation tools

Job description

Biogen, Inc. is seeking a Principal Scientist, Oral Formulation Development to provide scientific leadership for small molecule oral drug product development and technology transfer across clinical programs.

You will lead design, process development, and scale-up, driving manufacturability and regulatory readiness while partnering with manufacturing, quality, and external CDMOs to advance platforms and enable efficient portfolio execution.