Sr. Principal Scientist, Oral Drug Product Development
Job Location:
Cambridge, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
About This Role
Biogen is seeking aSr. Principal Scientist Oral Drug Product Developmentto provide scientificand strategicleadershipfor the development of small molecule oral drug products.This role leadsscientificandengineering effortssupportingformulation and process development across early- and late-stage programs.This technicalleadwill driveenabling technologies fortypicallylowsolubilityandlow permeabilitycompounds clinical manufacturing readiness technology transfer and commercialization.The Sr. Principal Scientist 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 Biogens oral drug product development capabilities.
WhatYoullDo
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 Biogens capabilities in oral drug product development.
Required Skills:
PhD inPharmaceutical SciencesChemical Engineering Chemistryor 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 functionsinfluence program strategy manage technical risk and communicate effectively with diverse stakeholders.
Experience mentoring developing or leadingscientists and engineers.
PreferredSkills:
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.
Additional Information
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 $10000 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 onto 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.
Required Experience:
Staff IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
