About the Role
Biogen is seeking a Director,Oral Drug ProductDevelopmentto provide scientificand strategicleadershipfor the development of small molecule oral drug productsThis role leadsscientificandengineering effortssupportingformulation and process development across early- and late-stage programsThis technicalleadwill driveenabling technologies fortypicallylowsolubilityandlow permeabilitycompounds, clinical manufacturing readiness, technology transfer, and commercializationThe Director serves as a senior drug product leaderandmentoron cross-functional CMC and asset teams, influencing development strategy, manufacturing readiness, and regulatory submissions.This rolewill alsobe responsible formanaging external partnerships andadvancingnew technologiesand workflows that strengthen Biogen’s oral drug product development capabilities.
WhatYou’llDo
Leadformulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing of small molecule oral dosage formsacross all stages of development
Develop enabling formulation approaches for challenging compounds, including poorly soluble, poorly permeable, unstable, or complex moleculessuch asorallydeliveredpeptides
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 andestablishmanufacturing strategies.
Mentor and developscientists and engineers supporting oral drug product development.
Oversee completion of drug product sections for regulatory submissionsandrelatedtechnical documentation.
Identify and implement new formulation technologies, predictive tools, digital workflows, and best practices that improve development efficiency and portfolio execution.
Who You Are
You 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 inPharmaceutical Sciences,Chemical Engineering, Chemistry,or a related scientific disciplinewith a minimum of 12years’ experience in oraldrug productdevelopment.
Demonstratedtrack recordleadingformulation and process development for oral solid dosage forms from early development through clinical manufacturing and/or late-stage development.
Experience withscale-up, technology transfer, clinical manufacturing, and external manufacturing organizations.
Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies.
Provenability to lead across functions,influence program strategy, manage technical risk, and communicate effectively with diverse stakeholders.
Experience mentoring, developing, or leadingscientists and engineers.
Preferred Skills:
Deepexpertisein 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 productand regulatory agency interaction experience
Strong understanding and hands on experience with oral solid dose manufacturing unit operations and manufacturability considerations.
Experience implementingnew technologies, digital tools, knowledge platforms, or best practices across multiple programs.
Demonstrated success managing external CDMO/CMO relationships and technology transfer activities.
Job Level: Management
Additional Information
The base compensation range for this role is: $188,000.00-$259,000.00
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:
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.
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.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities.
We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
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