Sr. Principal Scientist, Oral Drug Product Development (Biotech)

Location: Cambridge, Massachusetts, United States

Base compensation: $188,000–$259,000 per year

Company

hirify.global is a mid-sized biotechnology company developing life-changing medicines through scientific innovation and cross-functional collaboration.

What you will do

• Lead formulation design, process development, manufacturability assessment, scale-up, technology transfer, and clinical manufacturing for small-molecule oral dosage forms.
• Develop formulation approaches for poorly soluble, poorly permeable, unstable, and otherwise complex compounds, including orally delivered peptides.
• Represent drug product development on cross-functional CMC and asset teams spanning regulatory, quality, manufacturing, analytical, clinical pharmacology, DMPK, and external partners.
• Assess developability, manufacturability, biopharmaceutical performance, technical risk, and investment priorities to influence portfolio decisions.
• Establish manufacturing strategies, oversee readiness at internal and external sites, and complete drug product sections for regulatory submissions.
• Mentor scientists and engineers while implementing new formulation technologies, predictive tools, digital workflows, and development best practices.

Requirements

• PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline.
• Minimum of 12 years of experience in oral drug product development.
• Track record leading formulation and process development for oral solid dosage forms 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.
• Ability to lead across functions, influence program strategy, manage technical risk, communicate effectively, and mentor scientists and engineers.

Nice to have

• Expertise in 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 an NDA, MAA, or commercial product and interacting with regulatory agencies.
• Experience with oral solid-dose manufacturing unit operations, digital tools, knowledge platforms, or best practices.
• Experience managing external CDMO/CMO relationships and technology transfer activities.

Culture & Benefits

• Full-time employment with short- and long-term incentive opportunities, including cash bonuses and equity incentives.
• Medical, dental, vision, life, disability, and wellness benefits.
• Paid vacation, company holidays, personal-significance days, sick time, and parental leave.
• 401(k) plan with company matching and an employee stock purchase plan.
• Tuition reimbursement of up to $10,000 per calendar year.
• Inclusive environment focused on collaboration, learning, growth, and professional development.