Sr. Principal Scientist, Oral Drug Product Development (Cambridge, MA)

This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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   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   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   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 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   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: 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 reimburse]]>