Sr. Principal Scientist, Oral Drug Product Development

Biogen; Cambridge (MA); On-site; USD 188,000 - 259,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs including,

Vacation & holidays

Job summary

Biogen is seeking a Sr. Principal Scientist, Oral Drug Product Development to lead formulation design, process development, and technology transfer for small molecule oral dosage forms across development stages.

You will drive enabling formulation strategies for challenging compounds and collaborate with regulatory, quality, and manufacturing teams. You will mentor scientists, shape development strategies, and oversee documentation for regulatory submissions, ensuring readiness for clinical

Qualifications

• PhD with substantial experience in oral drug product development.
• Proven track record leading formulation and process development for oral solids from early to late-stage.
• Experience with scale-up, technology transfer, clinical manufacturing, and external CMOs.

Responsibilities

• Lead design of formulations, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing for small molecule oral dosage forms across development stages.
• Develop enabling formulation approaches for challenging compounds (poor solubility, poor permeability, instability).
• Serve as senior drug product representative on cross-functional teams, aligning regulatory, quality, manufacturing, analytics, clinical pharmacology and external partners.

Skills

Leadership

Cross-functional collaboration

CMC development

Regulatory communication

Education

PhD in Pharmaceutical Sciences/ Chemical Engineering/ Chemistry

Tools

Technology transfer

Job description

About This RoleBiogen is seeking a Sr. Principal Scientist, Oral Drug Product Development to provide scientific and strategic leadership for the development of small molecule oral drug products . This role leads s cie nt ifi c and en gin eering e ff orts supp orting formulation and process development across early- and late-stage programs . This t e chnical lead wil l d rive enabling technologies for typ ically low so lubil ity and lo w perm eabil ity compounds, clinical manufacturing readiness, technology transfer, and commercialization . The Sr. Principal Scientist serves as a senior drug product leader and mentor on cross-functional CMC and asset teams, influencing development strategy, manufacturing readiness, and regulatory submissions. 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 DoLead 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 su ch as orally delivered pe pti des .Serve as the senior 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. Provide strategic oversight and establish manufacturing strategies.Mentor and develop scientists and engineers supporting oral drug product development.Oversee completion of drug product sections for regulatory submissions and related technical documentation.Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.Who You AreYou are an innovative scientific leader with a passion for advancing drug development processes through rigorous science and data-driven decision-making. You excel at transforming experimental findings into development strategies, using deep technical expertise and sound scientific judgment to solve complex drug product challenges. Your expertise drives you to develop cutting-edge solutions ensuring manufacturability, scalability, and readiness for commercialization. You thrive in collaborative environments, influencing strategic decisions, and fostering alignment across diverse functions. Your mentoring skills inspire teams to achieve excellence, while your forward-thinking approach maximizes Biogen's capabilities in oral drug product development.Required Skills:PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry , or a related scientific discipline with a minimum of 1 2 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 and/or late-stage development.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.Proven ability to lead across functions, influence program strategy, manage technical risk, and communicate effectively with diverse stakeholders.Experience mentoring, developing , or leading scientists and engineers.Preferred Skills:Deep e xpertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering.Experience with late-stage development, commercial readiness, process characterization, or process validation.Experience supporting at least one NDA/MAA or commercial product and regulatory agency interaction experience .Strong understanding and hands on experience with oral solid dose manufacturing unit operations and manufacturability considerations.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.Job Level: ManagementAdditional InformationThe base compensation range for this role is: $188,000.00-$259,000.00Base 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 insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participationWhy 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.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.