Principal Scientist, Oral Formulation Development

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

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 fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.