Director, Oral Drug Product Development
About The Position
Biogen is seeking a Director, Oral Drug 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 Director 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.
Requirements
- 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.
Nice To Haves
- 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.
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, 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
