Sr. Principal Scientist, Oral Drug Product Development
Biogen
August 24, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Director, Oral Drug Product Development
Responsibilities:
- 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 (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; align regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
- Influence portfolio decisions based on developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
- Champion technology transfer, clinical manufacturing readiness, and scale-up 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 to improve development efficiency and portfolio execution.
Required Skills/Qualifications:
- PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline; minimum 12 years’ oral drug product development experience.
- Track record leading formulation and process development for oral solid dosage forms (early through clinical manufacturing and/or late-stage).
- 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.
- Ability to lead cross-functionally, influence strategy, manage technical risk, and communicate effectively.
- Experience mentoring, developing, or leading scientists and engineers.
Preferred Skills:
- Enabling tech expertise (amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, particle engineering).
- Late-stage development, commercial readiness, process characterization, and/or process validation experience.
- Experience supporting at least one NDA/MAA and regulatory agency interactions.
- Hands-on oral solid dose manufacturing unit operations and manufacturability experience.
- Experience implementing new technologies/digital tools/knowledge platforms across programs.
- Experience managing external CDMO/CMO relationships and technology transfer.
Benefits (if included):
- Medical, Dental, Vision, & Life insurances; fitness & wellness (reimbursement); short- and long-term disability; paid vacation (15+ days) and end-of-year shutdown; paid holidays; sick time; paid maternity and parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.
Responsibilities:
- 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 (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; align regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partner functions.
- Influence portfolio decisions based on developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities.
- Champion technology transfer, clinical manufacturing readiness, and scale-up 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 to improve development efficiency and portfolio execution.
Required Skills/Qualifications:
- PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or related discipline; minimum 12 years’ oral drug product development experience.
- Track record leading formulation and process development for oral solid dosage forms (early through clinical manufacturing and/or late-stage).
- 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.
- Ability to lead cross-functionally, influence strategy, manage technical risk, and communicate effectively.
- Experience mentoring, developing, or leading scientists and engineers.
Preferred Skills:
- Enabling tech expertise (amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, particle engineering).
- Late-stage development, commercial readiness, process characterization, and/or process validation experience.
- Experience supporting at least one NDA/MAA and regulatory agency interactions.
- Hands-on oral solid dose manufacturing unit operations and manufacturability experience.
- Experience implementing new technologies/digital tools/knowledge platforms across programs.
- Experience managing external CDMO/CMO relationships and technology transfer.
Benefits (if included):
- Medical, Dental, Vision, & Life insurances; fitness & wellness (reimbursement); short- and long-term disability; paid vacation (15+ days) and end-of-year shutdown; paid holidays; sick time; paid maternity and parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year); Employee Resource Groups participation.