About This Role
Biogen 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 scientific and engineering
efforts supporting formulation and process development across early- and
late-stage programs. This technical lead will drive enabling technologies
for typically low solubility and low permeability 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 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 such
as orally delivered peptides.
* 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 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 in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related
scientific discipline with a minimum of 12 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 expertise 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: 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:
* 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
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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.